{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,16]],"date-time":"2026-05-16T15:44:39Z","timestamp":1778946279057,"version":"3.51.4"},"reference-count":20,"publisher":"Springer Science and Business Media LLC","issue":"17","license":[{"start":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T00:00:00Z","timestamp":1541030400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2018,11,1]],"date-time":"2018-11-01T00:00:00Z","timestamp":1541030400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"funder":[{"DOI":"10.13039\/100000048","name":"American Cancer Society","doi-asserted-by":"publisher","award":["IRG13-043-01"],"award-info":[{"award-number":["IRG13-043-01"]}],"id":[{"id":"10.13039\/100000048","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["R01CA165609"],"award-info":[{"award-number":["R01CA165609"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100013191","name":"South Carolina Center of Economic Excellence","doi-asserted-by":"publisher","award":["11150-13-32600"],"award-info":[{"award-number":["11150-13-32600"]}],"id":[{"id":"10.13039\/100013191","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2018,11]]},"DOI":"10.1007\/s40265-018-1009-0","type":"journal-article","created":{"date-parts":[[2018,11,16]],"date-time":"2018-11-16T07:07:00Z","timestamp":1542352020000},"page":"1777-1781","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":55,"title":["Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court\u2019s Recent Rulings do not Solve Fundamental Barriers to Competition"],"prefix":"10.1007","volume":"78","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6384-1673","authenticated-orcid":false,"given":"Brian K.","family":"Chen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Y. Tony","family":"Yang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Charles L.","family":"Bennett","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2018,11,16]]},"reference":[{"issue":"13","key":"1009_CR1","doi-asserted-by":"publisher","first-page":"e594","DOI":"10.1016\/S1470-2045(14)70365-1","volume":"15","author":"CL Bennett","year":"2014","unstructured":"Bennett CL, Chen B, Hermanson T, Wyatt MD, Schulz RM, Georgantopoulos P, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol. 2014;15(13):e594\u2013605.","journal-title":"Lancet Oncol."},{"issue":"11","key":"1009_CR2","doi-asserted-by":"publisher","first-page":"1467","DOI":"10.1001\/jamaoncol.2017.1530","volume":"3","author":"YT Yang","year":"2017","unstructured":"Yang YT, Chen B, Bennett CL. Biosimilars\u2014curb your enthusiasm. JAMA Oncol. 2017;3(11):1467\u20138.","journal-title":"JAMA Oncol."},{"issue":"4","key":"1009_CR3","first-page":"3","volume":"7","author":"AW Mulcahy","year":"2018","unstructured":"Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand Health Q. 2018;7(4):3.","journal-title":"Rand Health Q"},{"issue":"12","key":"1009_CR4","doi-asserted-by":"publisher","first-page":"1186","DOI":"10.1001\/jama.2017.11930","volume":"318","author":"B Chen","year":"2017","unstructured":"Chen B, Yang YT, Bennett CL. Challenges to biosimilar substitution. Jama. 2017;318(12):1186.","journal-title":"Jama"},{"issue":"22","key":"1009_CR5","first-page":"2148","volume":"378","author":"B Chen","year":"2018","unstructured":"Chen B, Yang TY, Bennett C. Reply\u2014Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(22):2148.","journal-title":"N Engl J Med."},{"issue":"9","key":"1009_CR6","doi-asserted-by":"publisher","first-page":"791","DOI":"10.1056\/NEJMp1714908","volume":"378","author":"RG Frank","year":"2018","unstructured":"Frank RG. Friction in the path to use of biosimilar drugs. N Engl J Med. 2018;378(9):791\u20133.","journal-title":"N Engl J Med."},{"key":"1009_CR7","unstructured":"Sandoz Inc. v. Amgen Inc. 582 U.S. ___ 2017."},{"key":"1009_CR8","unstructured":"Oil States Energy Services, LLC v. Greene\u2019s Energy Group, LLC, et al.: 584 U.S. ___ 2018."},{"key":"1009_CR9","unstructured":"Bultman M. Biologic fights drive PTAB drug challenges to record high. Law360. 2018. \n                    https:\/\/www.law360.com\/articles\/1010653\/biologic-fights-drive-ptab-drug-challenges-to-record-high\n                    \n                  . Accessed May 10 2018."},{"key":"1009_CR10","unstructured":"Gifford CN. Boehringer Ingelheim Prevails in IPR Against AbbVie\u2019s\u2019 135 Humira Patent. Rothwell Figg. 2017. \n                    http:\/\/www.biosimilarsip.com\/2017\/07\/17\/boehringer-ingelheim-prevails-ipr-abbvies-135-humira-patent\/\n                    \n                  . Accessed 11 Oct 2018."},{"key":"1009_CR11","unstructured":"Stanton D. AbbVie: Humira\u2019s patent maze will keep US biosimilars away until at least 2022. Biopharma Reporter. 2015. \n                    https:\/\/www.biopharma-reporter.com\/Article\/2015\/11\/03\/AbbVie-Humira-s-patent-maze-to-keep-US-biosimilars-at-bay-until-2022\n                    \n                  . Accessed 11 Oct 2018."},{"issue":"3","key":"1009_CR12","doi-asserted-by":"publisher","first-page":"113","DOI":"10.5639\/gabij.2015.0403.026","volume":"4","author":"BJ Malkin","year":"2015","unstructured":"Malkin BJ. Biosimilars patent litigation in the EU and the US: a comparative strategic overview. GABI J Generics Biosimilars Initiative J. 2015;4(3):113\u20137.","journal-title":"GABI J Generics Biosimilars Initiative J."},{"key":"1009_CR13","unstructured":"Sohn J-Y. Samsung bioepis files lawsuit against AbbVie on Humira patents. Korea Herald. 2016 April 4."},{"key":"1009_CR14","unstructured":"Staff Reporter. Settled lawsuit paves way for Humira biosimilar in EU from October. BioPharma Reporter. 2018. \n                    https:\/\/www.biopharma-reporter.com\/Article\/2018\/04\/06\/Settled-lawsuit-paves-way-for-Humira-biosimilar-in-EU-from-October\n                    \n                  . Accessed 11 Oct 2018."},{"key":"1009_CR15","unstructured":"AbbVie, Amgen settlement sets Humira U.S. biosimilar launch for 2023. Reuters. 2017 September 28."},{"key":"1009_CR16","unstructured":"Shapiro-Barr T, Heimbecher R. Biosimilars: Poised to Turn to Inter Partes Review to Resolve Patent Disputes. Metropolitan Corporate Counsel. 2015. \n                    http:\/\/www.metrocorpcounsel.com\/articles\/32490\/biosimilars-poised-turn-inter-partes-review-resolve-patent-disputes\n                    \n                  . Accessed 13 Jan 2018."},{"key":"1009_CR17","unstructured":"Lund D. Members of Congress Express Concerns About Abuses of PTO\u2019s Inter Partes Review System. Center for the Protection of Intellectual Property. 2016. \n                    https:\/\/cpip.gmu.edu\/2016\/12\/09\/members-of-congress-express-concerns-about-abuses-of-ptos-inter-partes-review-system\/\n                    \n                  . Accessed 10 May 2018."},{"key":"1009_CR18","unstructured":"United States Government Accountability Office. Intellectual Property: Patent Office Should Define Quality, Reassess Incentives, and Improve Clarity. 2016."},{"key":"1009_CR19","unstructured":"Hirschler B, Shields M. Novartis launches first U.S. \u2018biosimilar\u2019 drug at 15 percent discount. Reuters. 2015. \n                    https:\/\/www.reuters.com\/article\/us-novartis-drug-idUSKCN0R30C220150903\n                    \n                  . Accessed 11 Oct 2018."},{"key":"1009_CR20","unstructured":"Davio K. Pfizer Launches Biosimilar Filgrastim, Nivestym, at a Substantial Discount. 2018. \n                    https:\/\/www.centerforbiosimilars.com\/news\/pfizer-launches-biosimilar-filgrastim-nivestym-at-a-substantial-discount\n                    \n                  . Accessed 11 Oct 2018."}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40265-018-1009-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-018-1009-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-018-1009-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2020,5,16]],"date-time":"2020-05-16T22:38:05Z","timestamp":1589668685000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40265-018-1009-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,11]]},"references-count":20,"journal-issue":{"issue":"17","published-print":{"date-parts":[[2018,11]]}},"alternative-id":["1009"],"URL":"https:\/\/doi.org\/10.1007\/s40265-018-1009-0","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,11]]},"assertion":[{"value":"16 November 2018","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"The author have no conflicts of interest to report. This article has not been submitted to any other publication.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This article was supported in part by Grants from the American Cancer Society (IRG13-043-01), the National Institute of Health (R01CA165609), the University of South Carolina and the Centers for Economic Excellence program of the state of South Carolina (11150-13-32600), and philanthropic gifts from Doris Levkoff Meddin and Frank P. and Josie M. Fletcher to the Smart State Center for Medication Safety.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Financial Support"}}]}}