{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T18:34:07Z","timestamp":1770834847150,"version":"3.50.1"},"reference-count":215,"publisher":"Cambridge University Press (CUP)","issue":"S4","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":731,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2019,1,1]],"date-time":"2019-01-01T00:00:00Z","timestamp":1546300800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2019]]},"abstract":"<jats:p>Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.<\/jats:p><jats:p>As recognized by several commentators, access to biologics manufacturing information is key to increasing competition in biologics markets. Without access to such information, making follow-on biologics is difficult and expensive, if not outright impossible. This is expected to be especially true for the highly anticipated class of interchangeable biologics, none of which has been approved by the FDA to date. Yet, it has long been the position of the brand-name pharmaceutical industry (Industry) that biologics manufacturing information is proprietary and, thus, may not be shared. Congress has subscribed to the Industry's position, prohibiting the FDA from disclosing regulatory filings submitted by developers of original biologics, including manufacturing information, to third parties. That prohibition not only undermines competition in biologics markets, but is also wasteful, potentially unethical, and poses unnecessary risks to the health and safety of patients.<\/jats:p><jats:p>This article makes the case for FDA sharing of original biologics manufacturing information with follow-on biologics developers. It is informed by the similar legal and commercial circumstances in the area of pesticides and the regulatory regime established by Congress in the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), which is administered by the Environmental Protection Agency (EPA). The article reviews the FIFRA regime, including its upholding as constitutional by the United States Supreme Court, and then examines its applicability to the area of biologics. The article concludes with a proposal for a similar regime to be incorporated into the pathway for approval of follow-on biologics as a means of increasing competition in biologics markets.<\/jats:p>","DOI":"10.1177\/1073110519898043","type":"journal-article","created":{"date-parts":[[2020,1,20]],"date-time":"2020-01-20T05:12:10Z","timestamp":1579497130000},"page":"54-78","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":4,"title":["The Case for Disclosure of Biologics Manufacturing Information"],"prefix":"10.1017","volume":"47","author":[{"given":"Yaniv","family":"Heled","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S1073110500022609_bib176","unstructured":"176. Ruckelshaus, 467 U.S. at 1007."},{"key":"S1073110500022609_bib60","doi-asserted-by":"crossref","first-page":"241","DOI":"10.2307\/3481134","article-title":"\u201cA New Look at Trade Secret Law: Doctrine in Search of Justification,\u201d","volume":"86","author":"Bone","year":"1998","journal-title":"California Law Rev."},{"key":"S1073110500022609_bib84","unstructured":"84. Id.; Federal Pesticide Control Act of 1971: Hearings Before the H. Comm. on Agric. supra note 66 at 331 (statement of Richard H. Wellman, Vice President, Process Chems. Div. of Unio Carbide Corp.) (arguing that newer and higher regulatory barriers were being placed before the original pesticide product developers and that the cost of developing the necessary data in support of product marketing applications was heavy)."},{"key":"S1073110500022609_bib192","doi-asserted-by":"crossref","first-page":"7","DOI":"10.1177\/1073110517750615","article-title":"\u201cBlueprint for Transparency at the U.S. Food and Drug Administration: Recommendations to Advance the Development of Safe and Effective Medical Products,\u201d","volume":"45","author":"Sharfstein","year":"2017","journal-title":"Journal of Law, Medicine and Ethics"},{"key":"S1073110500022609_bib200","doi-asserted-by":"crossref","DOI":"10.1093\/rheumatology\/kex278","article-title":"\u201cThe Process Defines the Product: What Really Matters in Biosimilar Design and Production?\u201d","volume":"56","author":"Vulto","year":"2017","journal-title":"Rheumatology"},{"key":"S1073110500022609_bib110","unstructured":"110. Id., at 1016."},{"key":"S1073110500022609_bib140","unstructured":"140. 42 U.S.C. \u00a7 262(k)(3)(A), & (4)."},{"key":"S1073110500022609_bib201","unstructured":"201. See Lucas v. S.C. Coastal Council, 505 U.S. 1003, 112 S. Ct. 2886, 120 L. Ed. 2d 798 (1992). The taking analysis would have changed had the purported taking pertained to real property. Id., at 1015."},{"key":"S1073110500022609_bib69","unstructured":"69. 7 U.S.C. \u00a7 136a(a)."},{"key":"S1073110500022609_bib173","first-page":"33","article-title":"\u201cTakings Issues in the Approval of Generic Biologics,\u201d","volume":"60","author":"Yoo","year":"2005","journal-title":"Food and Drug Law Journal"},{"key":"S1073110500022609_bib147","unstructured":"147. 42 U.S.C. \u00a7 262(k)(2)(iii)(II). Notably, BPCIA does list \u201cpublicly-available information with respect to the reference product or another biological product\u201d as an example of such \u201cadditional information\u201d and even requires that such information be submitted to FDA by follow-on product applicants. 42 U.S.C. \u00a7 262(k)(2)(iii)(I)-(II). However, the statutory language is open and does not preclude other kinds of information."},{"key":"S1073110500022609_bib38","article-title":"Biosimilars: Imitation Games","volume":"690","author":"Dahodwala","year":"2017","journal-title":"8 ACS Med. Chem. Lett"},{"key":"S1073110500022609_bib36","unstructured":"36. See Federal Trade Commission, Emerging Health Care Issues: Follow-On Biologic Drug Competition (2009): at iii (estimating the product development costs for small-molecule generic drugs is $1-5 million) [FTC 2009 Report], available at <https:\/\/www.ftc.gov\/sites\/default\/files\/documents\/reports\/emerging-health-care-issues-follow-biologic-drug-competition-federal-trade-commission-report\/p083901biologicsre-port.pdf> (last visited November 11, 2019)."},{"key":"S1073110500022609_bib103","unstructured":"103. Id., at 1007."},{"key":"S1073110500022609_bib203","unstructured":"203. See, e.g., 21 C.F.R. \u00a7 80.21 et seq. (2018) (requiring a request for certification by the FDA of a batch of color additives to be accompanied by a sample)."},{"key":"S1073110500022609_bib137","unstructured":"137. 21 U.S.C. \u00a7 331(j)."},{"key":"S1073110500022609_bib121","unstructured":"121. See also Ollinger and Fernandez-Cornejo, supra note 117, at 17 (highlighting additional similarities of the pesticide and pharmaceutical industries)."},{"key":"S1073110500022609_bib18","unstructured":"18. See Food & Drug Admin., \u201cBiosimilar Product Information,\u201d available at <https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilar-product-information> (last visited July 18, 2019)."},{"key":"S1073110500022609_bib51","unstructured":"51. 42 U.S.C. \u00a7 262(k)(4)."},{"key":"S1073110500022609_bib35","unstructured":"35. 21 U.S.C. \u00a7 355(j)(2)(iv) (2017)."},{"key":"S1073110500022609_bib6","unstructured":"6. See Food and Drug Administration, Considerations in Demonstrating Interchangeability with a Reference Product Guidance for Industry (2019), available at <https:\/\/www.fda.gov\/media\/124907\/download> [FDA Interchangeability Guidance]. The FDA Interchangeability Guidance, while clarifying how follow-on biologics developers may seek approval of their products as interchangeable with original biologics, does not change the underlying regulatory and commercial realities of biologics markets, which are described in detail later in this article. See infra notes 37-63 and accompanying text. Thus, the Guidance is unlikely to result in significant price competition in all but the few, most lucrative biologics markets. See infra discussion in the paragraph following note 58."},{"key":"S1073110500022609_bib180","unstructured":"180. See, e.g., Letter from Robert A. Long, supra note 45."},{"key":"S1073110500022609_bib85","unstructured":"85. See Union Carbide, 632 F.2d at 1016 (\u201c[I]t appears that the USDA made no public disclosures of data but did make use of data on hand in evaluating later applications.\u201d)."},{"key":"S1073110500022609_bib144","unstructured":"144. FDA Mission, available at <https:\/\/www.fda.gov\/about-fda\/what-we-do#mission> (last visited November 13, 2019)."},{"key":"S1073110500022609_bib17","unstructured":"17. See U.S. Food & Drug Admin., \u201cDrugs@FDA: FDA Approved Drug Products \u2013 Approval Date(s) and History, Letters, Labels, Reviews for BLA 125553,\u201d available at <https:\/\/www.access-data.fda.gov\/scripts\/cder\/daf\/index.cfm?event=overview.process&ApplNo=125553> (last visited April 3, 2018) [hereinafter Zarxio Approval] (citing the approval date of Zarxio as March 6, 2015)."},{"key":"S1073110500022609_bib118","doi-asserted-by":"crossref","first-page":"139","DOI":"10.1016\/S0167-7187(96)01049-1","article-title":"\u201cSunk Costs and Regulation in the U.S. Pesticide Industry,\u201d","volume":"16","author":"Ollinger","year":"1998","journal-title":"International Journal of Industrial Organization"},{"key":"S1073110500022609_bib131","unstructured":"131. The abuse of FDA Risk Evaluation and Mitigation Strategy (REMS) policies by brand-name pharmaceutical companies refusing to sell samples of their products to follow-on developers serves as both a lesson and warning against the institution of direct, unmediated dealings between original and follow-on pharmaceutical developers. See, e.g., Food and Drug Administration, Statement from FDA Commissioner Scott Gottlieb, M.D., on New Policies to Reduce the Ability of Brand Drug Makers to Use REMS Programs as a Way to Block Timely Generic Drug Entry, Helping Promote Competition and Access (May 31, 2018), available at <https:\/\/www.fda.gov\/news-events\/press-announcements\/statement-fda-commissioner-scott-gottlieb-md-new-policies-reduce-ability-brand-drug-makers-use-rems> (last visited November 11, 2019)."},{"key":"S1073110500022609_bib77","unstructured":"77. 7 U.S.C. \u00a7 136h(g)."},{"key":"S1073110500022609_bib132","unstructured":"132. 42 U.S.C. \u00a7 262(l)(2)(A) (\u201cthe [follow-on product] applicant \u2026 shall provide to the [original biologic developer] \u2026 the process or processes used to manufacture the biological product\u201d). For further discussion of the patent dance framework, see infra note 172."},{"key":"S1073110500022609_bib181","unstructured":"181. 21 U.S.C. \u00a7 331(j)."},{"key":"S1073110500022609_bib15","unstructured":"15. See infra note 183 and accompanying text; Price, supra note 5, at 1797."},{"key":"S1073110500022609_bib50","unstructured":"50. According to the FDA Interchangeability Guidance, a \u201cswitching study\u201d is a clinical study or studies used to determine the impact of alternating or switching between a proposed interchangeable biologic and the original product it seeks to imitate. See FDA Interchangeability Guidance supra note 6 at 5, note 12 and 9-14."},{"key":"S1073110500022609_bib24","unstructured":"24. As of December 2018, about a dozen biosimilar applications were pending approval at FDA. Levin, M. , Approved and Pending Biosimilar Applications, available at <https:\/\/www.mintz.com\/sites\/default\/files\/media\/documents\/2018-12-12\/Biosimilar-Chart-2018-12-12-.pdf> (last visited November 11, 2019)."},{"key":"S1073110500022609_bib168","unstructured":"168. 42 U.S.C. \u00a7 262(k)(7)(A)."},{"key":"S1073110500022609_bib5","first-page":"1769","article-title":"\u201cRegulating Secrecy,\u201d","volume":"91","author":"Price","year":"2016","journal-title":"Washington Law Review"},{"key":"S1073110500022609_bib47","unstructured":"47. As mentioned earlier, a few exceptions to this general rule exist in relatively small and well characterized biologics such as human growth hormone and insulin."},{"key":"S1073110500022609_bib157","unstructured":"157. See supra notes 13-16 and accompanying text."},{"key":"S1073110500022609_bib42","unstructured":"42. See Gitter supra note 40, at 561 note 21."},{"key":"S1073110500022609_bib125","unstructured":"125. See also supra note 62 and accompanying text."},{"key":"S1073110500022609_bib166","first-page":"4","volume-title":"Data Exclusivity Periods for Biologics: Updating Prior Analyses and Responding to Critiques","author":"Grabowski"},{"key":"S1073110500022609_bib16","unstructured":"16. See, e.g., Price, supra note 5, at 1792 and note 122; 1797 and notes 149\u201352; 1798 and note 153 (discussing the exclusivity in the product Premarin that has lasted for more than seventy years); Mixter, B. , \u201cAdministration Works on Increasing Rx Competition Due to Spending Concerns,\u201d Bloomberg Law, Pharmaceutical Law & Industry Report, April 15, 2015 (quoting Richard G. Frank, Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services)."},{"key":"S1073110500022609_bib95","unstructured":"95. Ruckelshaus, 467 U.S. at 987, 998-99."},{"key":"S1073110500022609_bib56","unstructured":"56. Id. Interestingly, the estimated development time of follow-on biologics is not much shorter than the time it takes to develop an original biologic. See Beall, R. F. et al., Nature Biotechnology 37 (2019): 708, 709 (finding that the median total pre-market development time for new biologics approved by the FDA between 2007 and 2016 was 10.6 or 12.4 years)."},{"key":"S1073110500022609_bib172","unstructured":"172. U.S. Const. Amend. V (\u201cnor shall private property be taken for public use, without just compensation.\u201d). See, e.g., Letter from Robert A. Long, supra note 45 at 2; H. Carver et al., supra note 40, at 698 (expressing the view that \u201capprove[al of] BLAs in reliance on preclinical and clinical safety and effectiveness data submitted in other BLAs \u2026 in the view of the authors, [is] inconsistent with \u2026 the Federal Trade Secrets Act, FDCA section 301(j), and the U.S. Constitution.\u201d); Epstein, supra note 64, at 299-300; see also supra note 45. Notably, this position appears to be inconsistent with BPCIA's similar, \u201copposite requirement\u201d that follow-on biologics applicants disclose their manufacturing information directly to original biologics developers so that the later could assess whether and to what extent follow-on applicants infringe any patents covering the original biologic. See 42 U.S.C. 262(l)(2) (A) (\u201cthe [follow-on biologic] applicant (A) shall provide the [original biologic developer] a copy of the application submitted to the Secretary \u2026 and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application.\u201d). Ultimately, the Supreme Court determined that doing so was optional for makers of follow-on biologics. See Sandoz Inc. v. Amgen Inc., 137 S.Ct. 1664, 1674 (2017) (affirming that makers of a follow-on biologics cannot be forced by injunction to engage in \u201cpatent dance\u201d under 42 U.S.C. \u00a7 262(l)(2)(A)). Yet, that holding was a surprise for many and did not reflect the intention of BPCIA's drafters, who sought to impose participation in BPCIA's \u201cpatent dance\u201d on makers of follow-on biologics. See Heled, supra note 4, at 119 n.37. Interestingly, in an Industry funded research, Prof. Richard Epstein has expressed the opinion that BPCIA's arrangements constitute a taking even without FDA consideration or disclosure of regulatory filings made in connection with original biologics marketing applications. See Epstein, supra note 64, at 294, 296, 300 (\u201ceven indirect reliance on the data in the prior application constitutes a taking\u201d and \u201cFDA's reliance the prior finding of safety, purity and potency in approving a biosimilar application appropriates the underlying trade secrets for the benefit of the biosimilar applicant. That partial loss of exclusive property rights in trade secrets thus triggers the application of the Takings Clause just as if the agency were accessing or releasing the data.\u201d)."},{"key":"S1073110500022609_bib146","unstructured":"146. 42 U.S.C. \u00a7 262(k)(2). BPCIA lists categories of \u201crequired information\u201d under subsection (k)(2)(i) but then gives the FDA the authority to \u201cdetermine, in [its] discretion,\u201d that some of the categories of information required under subsection (k)(2)(i) are \u201cunnecessary.\u201d Id."},{"key":"S1073110500022609_bib58","unstructured":"58. See supra discussion following note 8. To illustrate, the protracted legal battle surrounding the approval and launch of the first biosimilar approved in the United States, Zarxio (Filgrastim-sndz), has been ongoing at least since October 2014 and included, thus far, at least six rounds of litigation, including three before the Court of Appeals for the Federal Circuit and one before the United States Supreme Court, and raised numerous novel legal questions, e.g., whether BPCIA's patent dispute resolution scheme (a.k.a. \u201cpatent dance\u201d) is mandatory or optional, the preemption of state causes of action in light of BPCIA, as well as more mundane issues like patent claim construction, patent infringement, and more. See Amgen, Inc. v. Sandoz, Inc., No. 14-cv-04741, 2015 WL 1264756 (N.D. Cal. Mar. 19, 2015); Amgen, Inc. v. Sandoz, Inc., 794 F.3d 1347 (Fed. Cir. 2015) (affirming in part, vacating in part, remanding); Sandoz, Inc. v. Amgen, Inc., 137 S.Ct. 1664 (2017) (reversing in part, vacating in part); Amgen, Inc. v. Sandoz, Inc., 877 F.3d 1315 (Fed. Cir. 2017) (on remand, affirming); Amgen Inc. v. Sandoz Inc., 295 F. Supp. 3d 1062 (N.D. Cal. 2017) (granting Sandoz's motion for summary judgment of noninfringement of U.S. Patent No. 8,940,878); and Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. 2019) (affirming), in which, most recently, on June 7, 2019, Amgen filed a Petition for En Banc Rehearing that may result in yet another round of litigation."},{"key":"S1073110500022609_bib99","unstructured":"99. Id., at 1001\u20131004."},{"key":"S1073110500022609_bib135","unstructured":"135. See discussion infra note 178 and accompanying text."},{"key":"S1073110500022609_bib91","unstructured":"91. See, e.g., H.R. Rep. No. 95-663, at 41\u201343, 58."},{"key":"S1073110500022609_bib87","unstructured":"87. Federal Pesticide Control Act of 1971: Hearings Before the H. Comm. on Agric. supra note 66 at 331."},{"key":"S1073110500022609_bib68","unstructured":"68. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), ch. 125, 61 Stat. 163 (1947) (codified as amended at 7 U.S.C. \u00a7\u00a7 136\u2013136w-8 (2012))."},{"key":"S1073110500022609_bib34","unstructured":"34. 21 U.S.C. \u00a7 355(j)(2)(iii) (2017)."},{"key":"S1073110500022609_bib45","first-page":"1","article-title":"\u201cTowards Understanding the \u201cGeneric\u201d Debate about Biologics,\u201d","volume":"7","author":"Korwek","year":"2004","journal-title":"Journal of Biolaw and Business"},{"key":"S1073110500022609_bib119","unstructured":"119. Of further note in regard to a possible connection between the decrease in pesticide product registration and FPA is the potentially \u201cintervening\u201d factor of EPA's imposition in 1982 of additional testing requirements that further increased regulatory stringency. See id. (Ollinger, 1995), at 5 and 7 note 8."},{"key":"S1073110500022609_bib151","unstructured":"151. E.g., affordable Health Care for America Act, H.R. 3962, 111th Cong. \u00a7\u00a7 2575\u201377 (2009); Promoting Innovation and Access to Life-Saving Medicine Act, H.R. 1427, 111th Cong. (2009); Pathway for Biosimilars Act, H.R. 1548, 111th Cong.; Pathway for Biosimilars Act, H.R. 5629, 110th Cong. (2008); Access to Life-Saving Medicine Act, H.R. 1038, 110th Cong. (2007); Biologics Price Competition and Innovation Act of 2007, S. 1695, 110th Cong. (2007); Patient Protection and Innovation Biologic Medicines Act of 2007, H.R. 1956, 110th Cong. (2007)."},{"key":"S1073110500022609_bib41","doi-asserted-by":"crossref","first-page":"188","DOI":"10.1126\/science.aab1684","article-title":"\u201cAre Trade Secrets Delaying Biosimilars,\u201d","volume":"348","author":"Price","year":"2015","journal-title":"Science"},{"key":"S1073110500022609_bib179","unstructured":"179. Id., at 1005 (internal citation marks omitted); see also Penn Cent. Transp. Co. v. City of New York, 438 U.S. 104, 124, 98 S. Ct. 2646, 2659, 57 L. Ed. 2d 631 (1978) (\u201cA \u2018taking\u2019 may more readily be found when the interference with property can be characterized as a physical invasion by government \u2026 than when interference arises from some public program adjusting the benefits and burdens of economic life to promote the common good. Government hardly could go on if to some extent values incident to property could not be diminished without paying for every such change in the general law.\u201d)."},{"key":"S1073110500022609_bib187","unstructured":"187. Ruckelshaus, 467 U.S. at 1008."},{"key":"S1073110500022609_bib92","unstructured":"92. Id."},{"key":"S1073110500022609_bib12","unstructured":"12. See infra notes 136-138 and accompanying text."},{"key":"S1073110500022609_bib90","unstructured":"90. See H.R. Rep. No. 92-511, at 69, 72 (1971) (remarks of Reps. Foley & Dow); S. Rep. No. 92-970 at 12\u201313 (1972) (letter from the Attorney General); H.R. Rep. No. 95-663, at 41, 53\u201354 (1977) (reasoning provided by Rep. Fithian for his proposal to provide appropriate compensation in lieu of data exclusivity; letter from the EPA expressing preference for compensation of product developers for use of their data over exclusivity in such data)."},{"key":"S1073110500022609_bib158","doi-asserted-by":"crossref","DOI":"10.2307\/3481437","article-title":"\u201cIntellectual Property Rights and Standard-Setting Organizations,\u201d","volume":"90","author":"Lemley","year":"2002","journal-title":"California Law Review"},{"key":"S1073110500022609_bib153","unstructured":"153. For example, House Judiciary Chairman Jerrold Nadler (D-NY) and Subcommittee on Antitrust, Commercial, and Administrative Law Chairman David N. Cicilline (D-RI) released a joint statement about addressing the \u201cbully tactics\u201d adopted by large brand prescription drug companies, while House Judiciary Ranking Member Doug Collins (R-GA) and Subcommittee on Antitrust, Commercial, and Administrative Law Ranking Member Jim Sensenbrenner (R-WI) released a joint statement thanking Chairman Nadler and Subcommittee Chairman Cicilline and reaffirming their interest in continuing to \u201cwork[] together to promote competition and decrease pharmaceutical costs.\u201d Press Release, Congressman Jerry Nadler, House Judiciary Unanimously Passes Bipartisan Bills to Lower Prescription Drug Prices (April 30, 2019), available at <https:\/\/nadler.house.gov\/news\/documentsingle.aspx?DocumentID=393903> (last visited November 13, 2019). Senator Chuck Grassley (R-IA), Chairman of the Senate Finance Committee, has also sought to address concerns regarding rising prescription drug costs through hearings and bipartisan proposals. News Release, Sen. Chuck Grassley, Grassley Op-ed: Pharma execs should stop grandstanding and work to lower prescription prices (February 26, 2019), available at <https:\/\/www.grassley.senate.gov\/news\/news-releases\/grassley-op-ed-pharma-execs-should-stop-grandstandingand-work-lower-prescription> (last visited November 13, 2019)."},{"key":"S1073110500022609_bib53","unstructured":"53. See also Dahodwala and Sharfstein, supra note 38, at 692 (describing the development of follow-on biologics as a game)."},{"key":"S1073110500022609_bib174","unstructured":"174. Ruckelshaus, 467 U.S. at 1002."},{"key":"S1073110500022609_bib163","unstructured":"163. Even if one were to accept the estimates of $1.2-2.6 billion as true, the sales figures of many if not most original biologics make such numbers pale in comparison. See, e.g., A. Philip-pidis, \u201cTop 15 Best-Selling Drugs of 2018,\u201d Genetic Engineering & Biotechnology News March 11, 2019 (reporting the sales figures of top selling original biologics as ranging between $5.908-19.936 billion annually)."},{"key":"S1073110500022609_bib169","unstructured":"169. 42 U.S.C. \u00a7 262(k)(7)(B)."},{"key":"S1073110500022609_bib8","unstructured":"8. Like in my previous article, while this article focuses on the Industry's efforts in the United States, it is important to recognize that these efforts are not limited to this country alone and that local efforts are part of larger, well-coordinated strategies aimed at limiting follow-on biologics as a regulatory and commercial phenomenon worldwide. See Heled, supra note 4, at 113 n.7."},{"key":"S1073110500022609_bib74","unstructured":"74. Id."},{"key":"S1073110500022609_bib25","unstructured":"25. See also Heled, Y. , \u201cBiosimilars Are a Distraction,\u201d Health affairs Blog, April 8, 2019, available at <https:\/\/www.healthaffairs.org\/do\/10.1377\/hblog20190328.523018\/full\/> (November 11 2019)."},{"key":"S1073110500022609_bib112","unstructured":"112. Id., at 1019."},{"key":"S1073110500022609_bib11","unstructured":"11. The term \u201cfollow-on biologics,\u201d as it is used in this article, includes all different kinds of biopharmaceutical products that are developed and marketed so as to imitate, in whole or in part, original biologics and to benefit from scientific, clinical, and commercial information developed in connection with such original biologics without having to invest the resources that would have been necessary in order to gather that information independently. As such, the term \u201cfollow-on biologics\u201d includes biosimilars, interchangeable biosimilars (a.k.a. interchangeables), biobetters, and any subclass within these product classes."},{"key":"S1073110500022609_bib136","unstructured":"136. 42 U.S.C. \u00a7 262(j) (\u201cThe Federal Food, Drug, and Cosmetic Act \u2026 applies to a biological product subject to regulation under this section\u201d)."},{"key":"S1073110500022609_bib66","unstructured":"66. Federal Pesticide Control Act of 1971: Hearings Before the H. Comm. on Agric., Statement of Richard A. Wellman, Vice President and General Manager, Process Chemicals Division of Union Carbide Corp., New York, N.Y., 92d Cong. 170, 331 (1971) (arguing, on behalf of original pesticide product developers, that \u201cit is unfair to the company that developed \u2026 information to allow other people to use that information to secure registration of their own\u201d and proposing that \u201cdata in support of applications for registration made public pursuant to law shall not, without the permission of the registrant, be considered by the [EPA] in support of any other application.\u201d). As is evident from FPA, that position and proposal was, eventually, rejected by Congress."},{"key":"S1073110500022609_bib108","unstructured":"108. Id., at 1014 (citations omitted)."},{"key":"S1073110500022609_bib26","unstructured":"26. See supra note 6."},{"key":"S1073110500022609_bib122","unstructured":"122. See also Price, supra note 5, at 1804, note 189, 1804-1808 and Price and Rai, supra note 41, at 1053 (making a proposal to publicly disclose the Chemistry and Manufacturing Controls section of New Drug Applications (NDAs) and BLAs upon approval of original biologics; discussing the advantages of trade secret disclosure in the context of regulated industries in general)."},{"key":"S1073110500022609_bib123","unstructured":"123. See supra note 51 and accompanying text."},{"key":"S1073110500022609_bib162","doi-asserted-by":"crossref","first-page":"155","DOI":"10.1016\/S0167-6296(02)00126-1","article-title":"\u201cThe Price of Innovation: New Estimates of Drug Development Costs,\u201d","volume":"22","author":"DiMasi","year":"2003","journal-title":"Journal of Health Economics"},{"key":"S1073110500022609_bib126","unstructured":"126. While voluntary disclosure by original biologics developers would have achieved the same goals, given the structure of incentives in the area of biologics, it cannot be expected and must, therefore, be mandated by a legislative or regulatory measure. Another possibility is disclosure only in cases where an original biologic developer is unable to meet market demand, fails to maintain quality control of its products, and\/or is found to have broken the law somehow in a way that limits access to its products. See also Price, supra note 5, at 1808-10. This option, however, is also too limited as it will make instances of disclosure too rare to alleviate the competitive ills that plague most biologics markets, including ones that are not affected by original product developers' misconduct."},{"key":"S1073110500022609_bib9","unstructured":"9. Biologics Price Competition and Innovation Act of 2009, Pub. L. No. 111-148, \u00a7\u00a7 7001\u20137003, 124 Stat. 119 (2010). BPCIA was enacted as Title VII, Subtitle A of the affordable Care Act. Patient Protection and affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119, 804\u201321 (2010)."},{"key":"S1073110500022609_bib105","unstructured":"105. See id., at 1009\u201314 (discussing data submitted between October 22, 1972 and September 30, 1978)."},{"key":"S1073110500022609_bib120","unstructured":"120. Notably, the literature does recognize the debate surrounding the sharing of data by EPA and its resolution in FPA. See id. (Ollinger, 1995), at 5."},{"key":"S1073110500022609_bib183","unstructured":"183. See 21 C.F.R. \u00a7 60.151(f) (\u201cThe following data and information in biological product file are not available for public disclosure \u2026 (1) manufacturing methods or processes, including quality control procedures \u2026 (3) Quantitative or semiquantitative formulas.\u201d); 21 C.F.R. \u00a7 20.61(c) (\u201cData and information submitted or divulged to the Food and Drug Administration which fall within the definition of a trade secret or confidential commercial or financial information are not available for public disclosure.\u201d)."},{"key":"S1073110500022609_bib31","unstructured":"31. See infra note 59."},{"key":"S1073110500022609_bib52","first-page":"7","article-title":"\u201cBiosimilarity and Interchangeability in the Biologics Price Competition and Innovation Act of 2009 and FDA's 2012 Draft Guidance for Industry,\u201d","volume":"32","author":"Koyfman","year":"2017","journal-title":"Biotechnology Law Report"},{"key":"S1073110500022609_bib27","unstructured":"27. See id. and infra Part II."},{"key":"S1073110500022609_bib115","unstructured":"115. Id., at 1011."},{"key":"S1073110500022609_bib104","unstructured":"104. Id., at 1007\u201308."},{"key":"S1073110500022609_bib156","unstructured":"156. See, e.g., Letter from John. C. Yoo, supra note 64, at 2 and note 1. See also generally Carver (describing FDA hesitancy as one of the leading causes for the delay in the institution of a regulatory pathway for approval of follow-on biologics)."},{"key":"#cr-split#-S1073110500022609_bib1.1","unstructured":"1. See IQVIA Institute for Human Data Science, Medicine Use and Spending in the U.S. (2018): at 11, available at <https:\/\/www.iqvia.com\/-\/media\/iqvia\/pdfs\/institute-reports\/medicine-use-and-spending-in-the-us-a-review-of-2017-and-outlook-to-2022.pdf?_=1536097777009> (last visited November 11, 2019"},{"key":"#cr-split#-S1073110500022609_bib1.2","unstructured":"access requested) (\"Biologics grew by 12.6% in 2017, averaging 11.2% for the last five years as a variety of biologic treatments for autoimmune disorders, immunology and cancer came to the market\")"},{"key":"#cr-split#-S1073110500022609_bib1.3","unstructured":"IQVIA Institute for Human Data Science, 2018 and Beyond: Outlook and Turning Points (2018): at 20, available at <https:\/\/www.iqvia.com\/-\/media\/iqvia\/pdfs\/institute-reports\/2018-and-beyond-outlook-and-turning-points.pdf> (last visited November 11, 2019) (\"With the total market for biotech medicines reaching $168 billion across developed markets in 2016 \u2026\")"},{"key":"#cr-split#-S1073110500022609_bib1.4","unstructured":"EvaluatePharma, World Preview 2017, Outlook to 2022 (2017): at 6, available at <http:\/\/info.evaluategroup.com\/rs\/607-YGS-364\/images\/WP17.pdf> (last visited November 11, 2019) (\"Biologics to contribute 52% of the Top 100 product sales by 2022\")"},{"key":"#cr-split#-S1073110500022609_bib1.5","unstructured":"Blackstone, E. A. and Fuhr, J. P. Jr. , \"The Economics of Biosimilars,\" American Health & Drug Benefits, September 2013 (2013): at 469 (\"The average daily cost of a biologic in the United States is $45 compared with only $2 for chemical (small-molecule) drugs\")."},{"key":"#cr-split#-S1073110500022609_bib37.1","unstructured":"37. With some exceptions (e.g., human growth hormone and insulin), biologics are typically very large molecules with complex three-dimensional (and, possibly, quaternary) structures and appendages (e.g., oligosaccharide chains) that are very difficult to precisely characterize using current scientific methods. Moreover, at least some biologics consist of not a single API but a collection or mixture of structurally-related variations of a certain therapeutically-active molecule in a certain ratio between the different variations. See, e.g., Chhina, M. , U.S. Food & Drug Admin., Overview of Biological Products (2013): 8, available at <https:\/\/www.fda.gov\/downloads\/AboutFDA\/Transparency\/Basics\/UCM356666.pdf> (discussing how the structure of small molecules are known, yet in biological products the \"[s]tructure may or may not be completely defined or known\")"},{"key":"#cr-split#-S1073110500022609_bib37.2","unstructured":"U.S. Food & Drug Admin., Guidance for Industry: Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product (2015): 7, available at <https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm291134.pdf> (last visited November 11, 2019) (\"Using multiple, relevant, state-of-the-art methods can help define tertiary protein structure and, to varying extents, quaternary structure and can add to the body of information supporting biosimilarity. At the same time, a protein's three-dimensional conformation can often be difficult to define precisely using current physicochemical analytical technology.\")."},{"key":"S1073110500022609_bib171","first-page":"135","article-title":"\u201cLimits on Hard-to-Reproduce Inventions: Process Elements and Bio-technology's Compliance with the Enablement Requirement,\u201d","volume":"3","author":"Karshtedt","year":"2011","journal-title":"Hastings Science and Technology Law Journal"},{"key":"S1073110500022609_bib39","unstructured":"39. This reality is evident in the fact that since the enactment of BPCIA in 2010 through the time of writing of this article \u2014 over nine years \u2014 no follow-on biologics developer has attempted to seek approval for its biosimilar product as interchangeable with an already-approved original biologic. This is not due to a legal impossibility to do so. Even in the absence of specific guidance, BPCIA has granted the FDA authority to approve follow-on biosimilar products as interchangeable with existing products and follow-on product developers were free to file their applications for such approval at least since the enactment of BPCIA, in March 2010. That no follow-on biologics developer has done so since 2010 is, at least in part, due to the fact that follow-on product developers have been unable to establish identity or near-identity of their follow-on products to the original biologics they seek to imitate, as is done in small-molecule drugs under the Hatch-Waxman Act. At least as late as May 2015, the FDA's position was that \u201c[a]t this time, it would be difficult as a scientific matter for a prospective biosimilar applicant to establish interchangeability \u2026 given the statutory standard for interchangeability and the sequential nature of that assessment.\u201d Food & Drug Admin., Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; Guidance for Industry (May 2015): at 7, available at <https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM273001.pdf>."},{"key":"S1073110500022609_bib202","unstructured":"202. See, e.g., 37 C.F.R. \u00a7\u00a7 1.801 et seq. (2003) (requiring samples to be deposited with the USPTO)."},{"key":"S1073110500022609_bib78","unstructured":"78. 7 U.S.C. \u00a7 136a(c)(1)(F)(iii)."},{"key":"S1073110500022609_bib54","unstructured":"54. See Price and Rai, supra note 41, at 189."},{"key":"S1073110500022609_bib40","first-page":"555","article-title":"\u201cInnovators and Imitators: An Analysis of Proposed Legislation Implementing an Abbreviated Approval Pathway for Follow-on Biologics in the United States,\u201d","volume":"35","author":"Gitter","year":"2008","journal-title":"Florida State University Law Review"},{"key":"S1073110500022609_bib191","unstructured":"191. Id. See also Letter from John C. Yoo, supra note 64, at 6-7 (\u201cStatutory silence in a heavily regulated industry, the Court found \u2026 places applicants on notice that they cannot form reasonable investment-backed expectations that submitted data will not be used by the agency in the future.\u201d)."},{"key":"S1073110500022609_bib28","unstructured":"28. See also Fed. Trade Comm'n, supra note 22, at iii\u2013iv."},{"key":"S1073110500022609_bib199","unstructured":"199. See supra notes 37-42 and accompanying text."},{"key":"S1073110500022609_bib155","unstructured":"155. See discussion infra Part III.E.2."},{"key":"S1073110500022609_bib43","unstructured":"43. 21 C.F.R. \u00a7 601.2(a) (requiring \u201c[a] full description of manufacturing methods \u2026 [and] sample(s) representative of the product for introduction or delivery for introduction into interstate commerce."},{"key":"#cr-split#-S1073110500022609_bib154.1","unstructured":"154. See, e.g., We PAID (Protect American Investment in Drugs) Act of 2019, S. 2387, 116th Cong. (2019) (establishing a process for calculating a \"reasonable\" drug price)"},{"key":"#cr-split#-S1073110500022609_bib154.2","unstructured":"Efficiency and Transparency in Petitions Act, S. 660, 116th Cong. (2019) (amending requirements in the citizen petition process to prevent abuse by brand-name drug manufacturers)"},{"key":"#cr-split#-S1073110500022609_bib154.3","unstructured":"Accelerated Drug Approval for Prescription Therapies (ADAPT) Act, S. 658, 116th Cong. (2019) (creating an accelerated approval pathway for drugs that are legally approved in other countries)"},{"key":"#cr-split#-S1073110500022609_bib154.4","unstructured":"Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, S. 340, 116th Cong. (2019) (aimed at preventing abuse of risk evaluation and mitigation strategies (REMS) by creating a pathway for follow-on product manufacturers to purchase original product samples)"},{"key":"#cr-split#-S1073110500022609_bib154.5","unstructured":"Prescription Drug Price Relief Act, S. 102, 116th Cong. (2019) (terminating government-granted monopolies for drug manufacturers that charge excessive drug prices exceeding the median price in other countries)"},{"key":"#cr-split#-S1073110500022609_bib154.6","unstructured":"Prescription Drug Price Transparency Act, H.R. 1035, 116th Cong. (2019) (adding pharmacy benefits manager standards for the Medicare prescription drug program and the Medicare Advantage program to increase transparency of payment methods to pharmacies)"},{"key":"#cr-split#-S1073110500022609_bib154.7","unstructured":"and Bringing Low-Cost Options and Competition while Keeping incentives for New Generics (BLOCKING) Act of 2019, H.R. 938, 116th Cong. (2019) (seeking to prevent abuse of the Hatch-Waxman Act's 180-day generic exclusivity period)."},{"key":"S1073110500022609_bib161","doi-asserted-by":"crossref","first-page":"469","DOI":"10.1002\/mde.1360","article-title":"\u201cThe Cost of Biopharmaceutical RandD: Is Biotech Different,\u201d","volume":"28","author":"DiMasi","year":"2007","journal-title":"Managerial and Decision Economics"},{"key":"S1073110500022609_bib185","unstructured":"185. 18 U.S.C. 1905."},{"key":"S1073110500022609_bib197","unstructured":"197. See supra note 165 and accompanying text."},{"key":"S1073110500022609_bib134","unstructured":"134. A narrow tailoring of the disclosure arrangement and its close tying to the goal of bringing price competition to biologics markets in the United States would stem challenges to the constitutionality of the measure as effectuating destruction of all economically beneficial uses of trade secrets embodied in manufacturing information disclosed to follow-on developers. See Yoo, supra note 173, at 36 (\u201cunless government regulation completely deprives property of its entire value, courts will not find a per se taking to have occurred\u201d). It may also address other concerns having to do with protection afforded to original biologics in foreign pharmaceutical markets as well as with potential challenges to Ruckelshaus itself. For further insight into what such a challenge might entail, see Epstein, supra note 64, at 304-313."},{"key":"S1073110500022609_bib188","unstructured":"188. Notably, Prof. John Yoo has expressed the view that PHSA Section 301(j) similarly does not provide an express enough promise, under Ruckelshaus, not to disclose trade secrets in the specific context of approval of follow-on biologics. See Letter from John C. Yoo, supra note 64, at 9. But see Epstein, supra note 64, at 293 (arguing that BPCIA's reference to \u201cpublicly available information\u201d creates such an explicit promise)."},{"key":"S1073110500022609_bib72","unstructured":"72. 7 U.S.C. \u00a7 136a(c)(1)(F)(iii). This subsection further creates an elaborate scheme for resolution of disputes regarding the amount of the compensation, including a mandatory arbitration between the parties in case of a dispute. Id. Notably, disagreement between the parties regarding the compensation will not delay registration by the EPA. Id."},{"key":"S1073110500022609_bib145","unstructured":"145. But see Epstein, supra note 64, at 293-94 (in an Industry funded article, taking the opposite position that BPCIA precludes FDA consideration of information filed in original biologics regulatory filings as part of its evaluation of follow-on products marketing applications). Epstein's position, however, is based on his very narrow interpretation of Section 351(k)(3) that is not mandated by the statutory language."},{"key":"S1073110500022609_bib190","unstructured":"190. Id., at 1008-09."},{"key":"S1073110500022609_bib113","unstructured":"113. Id., at 1020."},{"key":"S1073110500022609_bib129","unstructured":"129. Public Health Service Act of 1944, Pub. L. No. 78-410, 58 Stat. 682 (1944) (codified at 42 U.S.C. \u00a7 201 et seq.)."},{"key":"S1073110500022609_bib170","unstructured":"170. 42 U.S.C. \u00a7 262(m)(2)(A). See also discussion supra note 14."},{"key":"S1073110500022609_bib10","unstructured":"10. See Heled supra note 4, at 115-19."},{"key":"S1073110500022609_bib152","unstructured":"152. See Sanders Amendment supra note 62. The Sanders Amendment does not mention manufacturing information."},{"key":"S1073110500022609_bib142","unstructured":"142. 42 U.S.C. \u00a7\u00a7 262(a)(2)(C)(I)."},{"key":"S1073110500022609_bib59","doi-asserted-by":"crossref","first-page":"1083","DOI":"10.1377\/hlthaff.2009.0196","article-title":"\u201cBiosimi-lars and the European Experience: Implications for the United States,\u201d","volume":"32","author":"Megerlin","year":"2013","journal-title":"Health affairs"},{"key":"S1073110500022609_bib141","unstructured":"141. 42 U.S.C. \u00a7\u00a7 262(i)."},{"key":"S1073110500022609_bib55","first-page":"469","article-title":"\u201cThe Economics of Biosimilars,\u201d","volume":"6","author":"Blackstone","year":"2013","journal-title":"American Health and Drug Benefits"},{"key":"S1073110500022609_bib73","unstructured":"73. Id."},{"key":"S1073110500022609_bib160","unstructured":"160. See, e.g., Gottlieb Statement supra note 139 (\u201cthe life science industry realizes one of the highest rates of investment in research and development \u2013 almost 19 percent of revenues, on average.\u201d); Atteberry et al., supra note 23 (discussing the profitability of biologics; bringing Humira as an example)."},{"key":"S1073110500022609_bib82","unstructured":"82. Federal Environmental Pesticide Control Act of 1972, Pub. L. No. 92-516, \u00a7\u00a7 3(c)(5)(C)\u2013(D), 86. Stat. 973, 980\u201381."},{"key":"S1073110500022609_bib149","first-page":"2273","article-title":"\u201cWhat Makes Ensuring Access to Affordable Prescription Drugs the Hardest Problem in Health Policy?\u201d","volume":"102","author":"Mello","year":"2018","journal-title":"Minnesota Law Review"},{"key":"S1073110500022609_bib189","unstructured":"189. See also Letter from John C. Yoo, supra note 64, at 10."},{"key":"S1073110500022609_bib57","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1177\/0098858815591509","article-title":"\u201cThe Legal and Regulatory Status of Biosimilars: How Product Naming and State Substitution Laws May Impact the United States Healthcare System,\u201d","volume":"41","author":"Paradise","year":"2015","journal-title":"American Journal of Law and Medicine"},{"key":"S1073110500022609_bib21","unstructured":"21. See Food & Drug Admin., \u201cCtr. for Drug Evaluation and Research, List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date,\u201d June 28, 2019, available at <https:\/\/www.fda.gov\/media\/89589\/download> (last visited November 11, 2019; hereinafter \u201cPurple Book\u201d)."},{"key":"S1073110500022609_bib2","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1038\/nrd.2018.42","article-title":"\u201cMarket Watch: Top Drugs and Companies by Sales in 2017,\u201d","volume":"17","author":"Urquhart","year":"2018","journal-title":"Nature Reviews Drug Discovery"},{"key":"S1073110500022609_bib198","unstructured":"198. See also Epstein supra note 64 at 315 and 324 (making a similar point, viewing BPCIA's \u201cspecial protections \u2026 to innovators \u2026 as the \u201cquid pro quo\u201d for removing at year 12 the innovator's otherwise permanent right to prevent competitors from benefitting from the government's use of those trade secrets\u201d but disagreeing that BPCIA's scheme would allow for FDA disclosure of trade secrets to follow-on biologics developers)."},{"key":"S1073110500022609_bib194","unstructured":"194. Ruckelshaus, 467 U.S. at 1016-19."},{"key":"S1073110500022609_bib7","unstructured":"7. The brand-name pharmaceutical industry (Industry or Pharmaceutical Industry, for short) includes the brand-name pharmaceutical and biopharmaceutical industries, their various, numerous official and unofficial lobbying arms under the leadership of the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), industry-funded patient groups, researchers, research institutions, medical salespersons, and more. Notably, when it comes to biologics the traditional lines between brand-name and follow-on\/generic parts of the industry are not as clear as they are in the small-molecule context. Still, with a few notable exceptions, it is possible to speak of efforts led by and on behalf of the brand-name biopharmaceutical industry, which are opposed to the interests of those parts of the industry that are focused on bringing follow-on biologics to market."},{"key":"S1073110500022609_bib107","unstructured":"107. Id."},{"key":"S1073110500022609_bib65","unstructured":"65. Federal Pesticide Act of 1978, Pub. L. No. 95-396, 92 Stat. 819 (codified at 7 U.S.C. \u00a7\u00a7 136\u2013136w-8)."},{"key":"S1073110500022609_bib167","unstructured":"167. Notably, original biologics developers' exclusivity in their products is further ensured internationally by similar extra-patent exclusivity arrangements such as the ones instituted under BPCIA as well as by foreign patents covering the original biologics. For further discussion of international implications of disclosure of original products' manufacturing information, see Price, supra note 5, at 1811."},{"key":"S1073110500022609_bib116","unstructured":"116. Note that the data is for registrations rather than applications for new pesticide products."},{"key":"S1073110500022609_bib83","unstructured":"83. See Union Carbide, 632 F.2d at 1016 (\u201cThis costly research and lengthy development process produce data that define the peculiar characteristics of the pesticide submitted for registration \u2026 [and] must be submitted to obtain registration.\u201d)."},{"key":"S1073110500022609_bib124","unstructured":"124. See also Price supra note 5, at 1798."},{"key":"S1073110500022609_bib133","unstructured":"133. This would be similar to FPA's grant of authority to EPA to share original pesticide manufacturing information with follow-on developers only when such disclosure \u201cis necessary to protect against an unreasonable risk of injury to health or the environment.\u201d See supra note 76 and accompanying text."},{"key":"S1073110500022609_bib100","unstructured":"100. Id., at 1005 (internal citation marks omitted)."},{"key":"S1073110500022609_bib150","first-page":"113","article-title":"\u201cThick as Thieves? Big Pharma Wields Its Power With the Help of Government Regulation,\u201d","volume":"5","author":"Sekerka","year":"2018","journal-title":"Emory Corporate Governance and Accountability Review"},{"key":"S1073110500022609_bib127","unstructured":"127. For the purpose of this proposal, \u201cmanufacturing information\u201d includes whatever information knowledge and materials necessary to create the most accurate replica of an original biologic as approved by the FDA. For further discussion of the possible need and legal feasibility of sharing the progenitor cell line, see discussion infra Part III.D.3."},{"key":"S1073110500022609_bib96","unstructured":"96. Ruckelshaus, 467 U.S. at 990, 999."},{"key":"S1073110500022609_bib139","unstructured":"139. 42 U.S.C. \u00a7 262(a)(2)(A). Notably, some biologics have traditionally been regulated and approved via the regulatory pathway reserved for small molecule drugs under FDCA. The FDA is expected to transition at least some of these products \u2014 e.g., insulin and human growth hormone \u2014 to regulation and licensure as biologics under PHSA. See Statement from FDA Commissioner Scott Gottlieb, M.D., on New Actions Advancing the Agency's Biosimilars Policy Framework, December 11, 2018, available at <https:\/\/www.fda.gov\/news-events\/press-announcements\/statement-fda-commissioner-scott-gottlieb-md-new-actions-advancing-agencys-biosimilars-policy> (last visited November 11, 2019) [Gottlieb Statement]. The FDA's set of authorities under FDCA make the discussion in this part also applicable, mutatis mutandis, to such biologics."},{"key":"S1073110500022609_bib61","doi-asserted-by":"crossref","first-page":"319","DOI":"10.1007\/s40259-018-0287-0","article-title":"\u201cThe End of Phase 3 Clinical Trials in Biosimilars Development?\u201d","volume":"32","author":"Frapaise","year":"2018","journal-title":"BioDrugs"},{"key":"S1073110500022609_bib195","unstructured":"195. Id., at 1016. Under the Tucker Act, \u201cThe United States Court of Federal Claims shall have jurisdiction to render judgment upon any claim against the United States founded either upon the Constitution, or any Act of Congress or any regulation of an executive department, or upon any express or implied contract with the United States, or for liquidated or unliquidated damages in cases not sounding in tort.\u201d 28 U.S.C. \u00a7 1491."},{"key":"S1073110500022609_bib62","doi-asserted-by":"crossref","first-page":"519","DOI":"10.1007\/s40259-018-0297-y","article-title":"\u201cComment on \u2018The End of Phase 3 Clinical Trials in Biosimilars Development?\u2019\u201d","volume":"32","author":"Webster","year":"2018","journal-title":"BioDrugs"},{"key":"S1073110500022609_bib75","unstructured":"75. FIFRA \u00a7\u00a7 10(d)(1)(A)\u2013(C); 7 U.S.C. \u00a7\u00a7 136a(c)(1)(F) (iv), 136h(d)."},{"key":"S1073110500022609_bib81","first-page":"15,623","article-title":"\u201cReorganization Plan No. 3 of 1970,\u201d","volume":"35","year":"1970","journal-title":"Federal Register"},{"key":"S1073110500022609_bib148","unstructured":"148. Notably, Professor John Yoo has taken a similar position with respect to FDA's authority to create a pathway for approval of generic biologics even before the enactment of BPCIA. See generally Yoo supra note 173, and especially at 41-43 (arguing that FDCA Section 301(j) does not preclude FDA's broad authority to create a pathway for approval of generic biologics and that \u201cFDA's decisions in this area should be based purely on policy considerations, and should not be deterred by Fifth Amendment concerns.\u201d)."},{"key":"S1073110500022609_bib22","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1038\/nbt.2550","article-title":"\u201cBuilding a Wall Against Biosimilars,\u201d","volume":"31","year":"2013","journal-title":"Nature Biotechnology"},{"key":"S1073110500022609_bib19","unstructured":"19. An additional five biosimilar market authorization applications were either rejected or withdrawn post-approval. European Meds. Agency, Medicines Search page, available at <https:\/\/www.ema.europa.eu\/en\/medicines\/field_ema_web_categories%253Aname_field\/Human\/search_api_aggregation_ema_medicine_types\/field_ema_med_biosimilar> (last visited November 11, 2019). But see Darrow, J. J. , \u201cBio-similar Approvals and the BPCIA: Too Soon to Give Up,\u201d Health affairs Blog, July 19, 2019, available at <https:\/\/www.healthaffairs.org\/do\/10.1377\/hblog20190718.722161\/full\/> (last visited November 11, 2019) (arguing that the comparison with approvals in Europe is better explained not by BPCIA but by regulatory delay in promulgating a pathway for evaluation and approval of biosimilars)."},{"key":"S1073110500022609_bib177","unstructured":"177. The Ruckelshaus Court did not consider the disclosure of regulatory filings by EPA to be per se taking and further emphasized that \u201cthis Court has generally been unable to develop any set formula for determining when justice and fairness require that economic injuries caused by public action must be deemed a compensable taking \u2026 The inquiry into whether a taking has occurred is essentially an ad hoc factual inquiry.\u201d Ruckelshaus, 467 U.S. at 1005. See also Letter from John A. Yoo, supra note 64, at 3-4."},{"key":"S1073110500022609_bib67","unstructured":"67. See Ruckelshaus v. Monsanto Co., 467 U.S. 986, 1006\u201307 (1984) (holding that EPA's consideration or disclosure of data submitted by an original product developer to the agency did not constitute an unconstitutional taking regardless of whether such data included trade secrets so long as parties submitting such data were on notice that the agency might disclose the data so prior to submitting its data); Union Car-bide Agric. Prods. Co. v. Costle, 632 F.2d 1014, 1017 (2d Cir. 1980) (reversing a temporary restraining order against the implementation of FPA)."},{"key":"S1073110500022609_bib14","unstructured":"14. Under BPCIA, original biologics developers benefit from a twelve-year market exclusivity period during which the FDA may not approve applications for follow-on products seeking to imitate the original biologic. 42 U.S.C. \u00a7 262(k)(7)(A). In addition, BPCIA creates a four-year data exclusivity period during which the FDA is not allowed to receive applications for follow on products that seek to imitate the original biologics. Both these market and data exclusivity periods may then be supplemented by an additional period of six months of exclusivity for putting the original biologic through additional clinical studies in pediatric populations, bringing the market and data exclusivity period to a total of 12.5 and 4.5 years respectively. 42 U.S.C. \u00a7 262(m)(2)(A). For further discussion of these and other exclusivities available in original biologics, see also discussion infra notes 168-171 and accompanying text."},{"key":"S1073110500022609_bib94","unstructured":"94. United States Const. Amend. V (\u201cnor shall [any person] \u2026 be deprived of \u2026 property, without due process of law; nor shall private property be taken for public use, without just compensation.\u201d)."},{"key":"S1073110500022609_bib130","unstructured":"130. Congress has nearly unlimited discretion in determining the scope of disclosure under the statute. See Ruckelshaus, 467 U.S. at 1016 (\u201cIt is enough for us to state that the optimum amount of disclosure to the public is for Congress, not the courts, to decide, and that the statute embodies Congress' judgment on that question.\u201d)."},{"key":"S1073110500022609_bib79","unstructured":"79. See Union Carbide, 632 F.2d at 1016 (\u201cAs enacted in 1947, FIFRA did not specifically prohibit the USDA from publicly disclosing submitted data or from using data supplied by one applicant to determine whether to register a pesticide offered subsequently by another.\u201d)."},{"key":"S1073110500022609_bib93","unstructured":"93. Federal Pesticide Act of 1978, Pub. L. No. 95-396, 92 Stat. 819 (codified at 7 U.S.C. \u00a7\u00a7 136\u2013136w-8)."},{"key":"S1073110500022609_bib128","unstructured":"128. Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified at 21 U.S.C. \u00a7 301 et seq.)."},{"key":"S1073110500022609_bib30","unstructured":"30. The hallmark of generic pharmaceutical products is their fungibility with the product they seek to imitate. This quality, once recognized by the FDA, allows for replacement of the original product with its follow-on version at the pharmacy level and often \u2014 depending on state substitution laws \u2014 without involvement of the prescribing physician. Follow-on biologics that are not approved by the FDA as interchangeable, however, cannot be similarly replaced by pharmacists, and so the competitive challenge they pose to original biologics is more akin to the kind of competition posed by \u201cme-too\u201d drugs, namely standalone pharmaceutical products that are indicated for the same disease or condition but are not clinically fungible. Examples of me-too drugs include the numerous cholesterol-lowering drugs that followed lovastatin (atorvastatin, fluvastatin, pitavastatin, simvastatin, pravastatin, and rosuvastatin) and hypertension drugs that followed captopril (benazepril, zofenopril, perindopril, trandolapril, enalapril, lisinopril, and ramipril). Pharmaceutical companies typically develop \u201cme-too\u201d drugs where the potential market for a certain condition is sufficiently lucrative to support more than one product. Notably, the Federal Trade Commission had reached a similar conclusion as early as 2009 (pre-BPCIA). See \u201cEmerging Health Care Issues,\u201d supra note 22, at iii (\u201ccompetition from FOB drug entry is likely to resemble brand-to-brand competition, rather than brand-to-generic drug competition.\u201d). See also T. Woodage, \u201cBlinded by (a Lack of) Science: Limitations in Determining Therapeutic Equivalence of Follow-On Biologics and Barriers to Their Approval and Commercialization,\u201d Stanford Technology Law Review (2012): at 9 (predicting that \u201cas currently structured, BPCIA is not likely to result in the dramatic reductions in healthcare costs\u201d)."},{"key":"S1073110500022609_bib178","unstructured":"178. Ruckelshaus, 467 U.S. at 987 (holding that FPA's data use and disclosure provisions did not violate the Fifth Amendment with respect to data submitted prior to October 22, 1972)."},{"key":"S1073110500022609_bib46","unstructured":"46. See also Carver et al., supra note 40, at 699 and notes 219\u201325 (discussing how the Industry's assertion of its position that regulatory submissions made in connection with BLAs are proprietary and confidential successfully dissuaded the FDA from attempting to develop a regulatory pathway for the approval of generic biologics based on its existing authorities under FDCA and the Public Health Service Act)."},{"key":"S1073110500022609_bib88","unstructured":"88. Id.; see also H.R. Rep. No. 95-663, at 41\u201342, 58."},{"key":"S1073110500022609_bib186","unstructured":"186. Pub. L. 114\u2013153, 130 Stat. 376 (2016) (codified at 18 U.S.C. \u00a7 1836, et seq.)."},{"key":"S1073110500022609_bib106","unstructured":"106. Id., at 1008\u201309. The Supreme Court recognized, however, that this was not the case with respect to data submitted between October 22, 1972 and September 30, 1978. See id., at 1013\u201314."},{"key":"S1073110500022609_bib164","unstructured":"164. 42 U.S.C. \u00a7 262(k)(7)."},{"key":"S1073110500022609_bib196","unstructured":"196. See supra notes 164-166 and accompanying text."},{"key":"S1073110500022609_bib44","unstructured":"44. See infra notes 136-138 and accompanying text."},{"key":"S1073110500022609_bib159","unstructured":"159. See, e.g., Heled supra note 4, at 129-130 (describing the case of Amgen's twenty-three years of monopoly in its filgrastim product, Neupogen)."},{"key":"S1073110500022609_bib165","doi-asserted-by":"crossref","first-page":"479","DOI":"10.1038\/nrd2532","article-title":"\u201cFollow-on Biologics: Data Exclusivity and the Balance Between Innovation and Competition,\u201d","volume":"7","author":"Grabowski","year":"2008","journal-title":"Nature Reviews Drug Discovery"},{"key":"S1073110500022609_bib70","unstructured":"70. Id. In the context of FIFRA, the safety and benefits of a product are considered under the title of \u201cunreasonable adverse effects on the environment,\u201d which is defined as \u201c(1) any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary risk from residues that result from a use of a pesticide in or on any food\u2026. [including] the risks and benefits of public health pesticides separate from the risks and benefits of other pesticides. In weighing any regulatory action concerning a public health pesticide under this subchapter, the Administrator shall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlled by the pesticide.\u201d 7 U.S.C. \u00a7 136(bb)."},{"key":"S1073110500022609_bib3","first-page":"203","article-title":"\u201cThe Comparability Conundrum: Biosimilars in the United States, Europe and Canada,\u201d","volume":"66","author":"Courage","year":"2011","journal-title":"Food and Drug Law Journal"},{"key":"#cr-split#-S1073110500022609_bib13.1","unstructured":"13. See, e.g., Chatterji, A. et al., The Follow-On Biologics Market: Enter at Your Own Risk (2011): at 7, available at <https:\/\/papers.ssrn.com\/sol3\/Delivery.cfm\/SSRN_ID1969973_code405577.pdf?abstractid=1969973&mirid=1> (last visited November 11, 2019) (while small molecules are typically covered by 8-10 patents, biologics typically have up to 50-70 patents covering the product's methods of use and manufacturing process)"},{"key":"#cr-split#-S1073110500022609_bib13.2","doi-asserted-by":"crossref","unstructured":"Koons, C. , \"This Shield of Patents Protects the World's Best-Selling Drug,\" Bloomberg Businessweek, September 7, 2017. The phenomenon of the multitude of overlapping patents covering a specific technology or product has come to be known as a \"patent thicket.\" See Shapiro, C. , \"Navigating the Patent Thicket: Cross Licenses, Patent Pools, and Standard Setting,\" in Jaffe, A. B. et al., eds., Innovation Policy and the Economy (2001): at 119, 120, available at <http:\/\/faculty.haas.berkeley.edu\/shapiro\/thicket.pdf> (defining a patent thicket as a dense web of overlapping intellectual property rights that a company must hack its way through in order to actually commercialize new technology).","DOI":"10.1086\/ipe.1.25056143"},{"key":"S1073110500022609_bib117","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1017\/S1068280500001660","article-title":"\u201cInnovation and Regulation in the Pesticide Industry,\u201d","volume":"27","author":"Ollinger","year":"1998","journal-title":"Agricultural and Resource Economics Review"},{"key":"S1073110500022609_bib33","unstructured":"33. 21 U.S.C. \u00a7 355(j)(2)(ii) (2017)."},{"key":"S1073110500022609_bib89","unstructured":"89. See H.R. Rep. No. 95-663, at 41 (reasoning provided by Rep. Thone for his proposal of a ten-year period of data exclusivity)."},{"key":"S1073110500022609_bib71","unstructured":"71. 7 U.S.C. \u00a7 136a(c)(1)(F)(i). See also Envtl. Prot. Agency Office of Pesticide Programs, Questions and Answers\u2013Exclusive Use Data Protection for Minor Use Registrations 2 (2014), available at <http:\/\/www.epa.gov\/pesticides\/minoruse\/exclusive-use-questions.pdf, archived at <http:\/\/perma.cc\/BXM9-UMSM> (last visited December 16, 2019). In 1998, Congress added to FIFRA an option to extend the ten-year data exclusivity period by one year for every three new \u201cminor uses\u201d approved by the EPA for the original pesticide product. 7 U.S.C. \u00a7 136a(c)(1)(F)(ii). Notably, such extension is only available up to three times in each pesticide product (up to a total of thirteen years of data exclusivity) and cannot be granted for \u201cminor uses\u201d registered more than seven years after the onset of the ten-year data exclusivity period. Id. To prevent abuse of such extensions, FIFRA instructs the EPA to grant one-year extensions only after consulting with the Secretary of Agriculture and subject to a determination that certain public policy considerations are applicable. See 7 U.S.C. \u00a7 136a(c)(1)(F)(ii)(I)\u2013(IV). These considerations are: \u201c(I) there are insufficient efficacious alternative registered pesticides available for the use [in a particular crop]; (II) the alternatives to the minor use pesticide pose greater risks to the environment or human health; (III) the minor use pesticide plays or will play a significant part in managing pest resistance; or (IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.\u201d. Id."},{"key":"S1073110500022609_bib98","unstructured":"98. Ruckelshaus, 467 U.S. at 987. The Supreme Court held that the data submitted between October 22, 1972 and September 30, 1978 was subject to another set of amendments to FIFRA that were in force prior to the enactment of FPA and that allowed a data submitter to protect its trade secrets from internal use by EPA by designating relevant data as trade secrets at the time of submission, provided that the EPA agreed with the designation. Id., at 1010-11. The Ruckelshaus Court viewed these arrangements as creating an explicit guarantee of \u201can extensive measure of confidentiality and exclusive use \u2026 [which] formed the basis of a reasonable investment-backed expectation.\u201d Id., at 1011."},{"key":"S1073110500022609_bib29","unstructured":"29. See U.S. Cong., Office of Tech. Assessment, Pharmaceutical R&D: Costs, Risks and Rewards, OTA-H-522 (1993): at 7, available at <ota.fas.org\/reports\/9336.pdf> (last visited November 11, 2019) (defining \u201cme too\u201d drugs)."},{"key":"S1073110500022609_bib4","article-title":"\u201cFollow-On Biologics Are Set Up to Fail,\u201d","volume":"113","author":"Heled","year":"2018","journal-title":"University of Illinois Law Review Online"},{"key":"S1073110500022609_bib49","unstructured":"49. See 42 U.S.C. \u00a7 262(k)(2)(A)(I)(bb)-(cc) (requiring that applications for marketing approval of follow-on biologics include animal studies and \u201ca clinical study or studies \u2026 that are sufficient to demonstrate safety, purity, and potency in 1 or more appropriate conditions of use for which the [original] product is licensed and intended to be used\u201d)."},{"key":"S1073110500022609_bib111","unstructured":"111. Id., at 1016\u201319."},{"key":"S1073110500022609_bib64","first-page":"285","article-title":"\u201cThe Constitutional Protection of Trade Secrets and Patents Under the Biologics Price Competition and Innovation Act of 2009,\u201d","volume":"66","author":"Epstein","year":"2011","journal-title":"Food and Drug Law Journal"},{"key":"S1073110500022609_bib80","unstructured":"80. See Federal Pesticide Control Act of 1971: Hearings Before the H. Comm. on Agric., supra note 66 at 170 (Statement of W.B. Ennis, Jr., Chief of Crops Protection Research Breachdd, U.S. Dep't of Agric.) (\u201cSince 1940 we have witnessed agricultural changes\u2026. This has come about primarily because of \u2026 control of damaging weeds, diseases, insects, and other pests and parasites.\u201d). The concerns that underlie FIFRA's data protection framework are highly similar to those that guide the regulation of biologics, including human and animal health, conservation of societal resources, and access to technologically innovative products."},{"key":"S1073110500022609_bib109","unstructured":"109. Ruckelshaus, 467 U.S. at 1014\u201315 (emphases added)."},{"key":"S1073110500022609_bib97","unstructured":"97. Id.; see also Union Carbide, 632 F.2d at 1017."},{"key":"S1073110500022609_bib76","unstructured":"76. 7 U.S.C. \u00a7 136h(d)(1)."},{"key":"S1073110500022609_bib101","unstructured":"101. Id., at 1005\u201306."},{"key":"S1073110500022609_bib182","unstructured":"182. See 42 U.S.C. \u00a7 262(j) (\u201cThe Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] \u2026 applies to a biological product subject to regulation under this section\u201d)."},{"key":"S1073110500022609_bib63","unstructured":"63. See also Price, supra note 5, at 1770, 1777, 1784\u20131793 (making the observation that, despite BPCIA, biologics are \u201cwildly expensive and look to stay that way\u201d and concluding that the lack of competition in biologics markets is attributable to the combination of trade secrecy and FDA regulation)."},{"key":"S1073110500022609_bib175","unstructured":"175. Arguably, such a change in the law would also render unreasonable any expectations that regulatory filings made subsequent to the law's going into effect would be kept confidential. See also Letter from John C. Yoo, supra note 64, at 6)."},{"key":"S1073110500022609_bib143","unstructured":"143. 42 U.S.C. \u00a7\u00a7 262(i)."},{"key":"S1073110500022609_bib23","unstructured":"23. See also Building a Wall Against Biosimilars supra note 22, at 264 (making the similar argument that biosimilars markets are not \u201cmolded\u201d to foster a reality where \u201cbetter products do better, and equivalent products compete on price.\u201d); Atteberry, P. et al., \u201cBiologics Are Natural Monopolies (Part 1): Why Biosimilars Do Not Create Effective Competition,\u201d Health Affairs Blog, April 15, 2019, available at <https:\/\/www.healthaffairs.org\/do\/10.1377\/hblog20190405.396631\/full\/> (last visited November 11, 2019). But cf. Darrow, supra note 19 (arguing that anti-competitiveness is not a hallmark of biologics as such; bringing two examples of sharp price drops subsequent to biosimilars' market entry in Europe)."},{"key":"S1073110500022609_bib138","unstructured":"138. See 21 C.F.R. \u00a7 60.151(f) (\u201cThe following data and information in biological product file are not available for public disclosure \u2026 (1) manufacturing methods or processes, including quality control procedures\u2026. (3) Quantitative or semiquantitative formulas.\u201d); 21 C.F.R. \u00a7 20.61(c) (\u201cData and information submitted or divulged to the Food and Drug Administration which fall within the definition of a trade secret or confidential commercial or financial information are not available for public disclosure.\u201d)."},{"key":"S1073110500022609_bib193","unstructured":"193. Ruckelshaus, 467 U.S. at 1005."},{"key":"S1073110500022609_bib102","unstructured":"102. Id., at 1006\u201307."},{"key":"S1073110500022609_bib32","unstructured":"32. Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984) (codified as amended at 21 U.S.C. \u00a7 355 (2012))."},{"key":"S1073110500022609_bib86","unstructured":"86. See, e.g., H.R. Rep. No. 95-663, at 41\u201342, 58 (1977) (describing the dispute surrounding the definition of proprietary information)."},{"key":"S1073110500022609_bib20","unstructured":"20. As of July 18, 2019, searches for biosimilar products available for purchase in goodrx.com and planetdrugsdirect.com indicate that only the following products are currently marketed and available in the United States: Zarxio (Filgrastimsndz), Inflectra (Infliximab-dyyb), Erelzi (Etanercept-szzs), Renflexis (Infliximab-abda), Retacrit (epoetin alfa-epbx), Fulphila (pegfilgrastim-jmdb), Nivestym (filgrastim-aafi), and Udenyca (pegfilgrastim-cbqv). In addition, on July 18, 2019, Amgen and Allergan's announced that they are launching two other biosimilars: Mvasi (Bevacizumab-awwb) and Kanjinti (Trastuzumab-anns). See Amgen, Amgen And Allergan's MVASI (bevacizumab-awwb) And KANJINTI (trastuzumabanns) Now Available in the United States, Press Release, July 18, 2019, available at <http:\/\/investors.amgen.com\/news-releases\/news-release-details\/amgen-and-allergans-mvasitmbevacizumab-awwb-and-kanjintitm\/> (last visited November 11, 2019)."},{"key":"S1073110500022609_bib184","unstructured":"184. See Letter from Robert A. Long, supra note 45."},{"key":"S1073110500022609_bib48","unstructured":"48. See 42 U.S.C. \u00a7 262(k)(2)(A)(I)(aa) (requiring that applications for marketing approval of follow-on biologics include \u201canalytical studies that demonstrate that the [follow-on] product is highly similar to the reference product notwithstanding minor differences in clinically inactive components\u201d.). See also Price supra note 5, at 1796-1797."},{"key":"S1073110500022609_bib114","unstructured":"114. Id., at 998 (quoting the district court opinion; brackets in origin)."}],"container-title":["Journal of Law, Medicine &amp; Ethics"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1073110519898043","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1073110519898043","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.cambridge.org\/core\/services\/aop-cambridge-core\/content\/view\/S1073110500022609","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,1,14]],"date-time":"2021-01-14T12:56:54Z","timestamp":1610629014000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.cambridge.org\/core\/product\/identifier\/S1073110500022609\/type\/journal_article"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019]]},"references-count":215,"journal-issue":{"issue":"S4","published-print":{"date-parts":[[2019]]}},"alternative-id":["S1073110500022609"],"URL":"https:\/\/doi.org\/10.1177\/1073110519898043","relation":{},"ISSN":["1073-1105","1748-720X"],"issn-type":[{"value":"1073-1105","type":"print"},{"value":"1748-720X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019]]}}}