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The article then explores the potential of an abbreviated biologics license application pathway to market\u2014akin to the market entry pathway for generics\u2014as a policy lever for improving biologics drug price competition, drug affordability and expanded access.<\/jats:p>","DOI":"10.1007\/s43441-026-00961-9","type":"journal-article","created":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T14:58:24Z","timestamp":1775573904000},"page":"925-928","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["The Future of Biologics: Lessons from Hatch\u2013Waxman"],"prefix":"10.1007","volume":"60","author":[{"given":"Brian J.","family":"Miller","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"Woodcock","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,4,7]]},"reference":[{"issue":"14","key":"961_CR1","doi-asserted-by":"publisher","first-page":"806","DOI":"10.1093\/ajhp\/zxaf092","volume":"82","author":"EM Tichy","year":"2025","unstructured":"Tichy EM, Rim MH, Cuellar S, Tadrous M, Schumock GT, Johnson TJ, et al. National trends in prescription drug expenditures and projections for 2025. Am J Health Syst Pharm. 2025;82(14):806\u201321. https:\/\/doi.org\/10.1093\/ajhp\/zxaf092.","journal-title":"Am J Health Syst Pharm"},{"key":"961_CR2","unstructured":"\u201cBiologics market: 2025 \u2013 2030.\u201d Grand view research 2025. Available from: https:\/\/www.grandviewresearch.com\/industry-analysis\/biologics-market Accessed 20 Mar 2026"},{"issue":"12","key":"961_CR3","doi-asserted-by":"publisher","first-page":"1355","DOI":"10.18553\/jmcp.2024.30.12.1355","volume":"30","author":"S Niu","year":"2024","unstructured":"Niu S, Happe LE, Abuloha S, Svensson M. Concentration of spending and share of specialty drug spending in Medicare Part D over a 10-year period. J Manag Care Spec Pharm. 2024;30(12):1355\u201363. https:\/\/doi.org\/10.18553\/jmcp.2024.30.12.1355.","journal-title":"J Manag Care Spec Pharm"},{"key":"961_CR4","unstructured":"\u201cCompetition in prescription drug markets, 2017\u20132022.\u201d Assistant secretary for planning and evaluation December 2023. Available from: https:\/\/aspe.hhs.gov\/sites\/default\/files\/documents\/1aa9c46b849246ea53f2d69825a32ac8\/competition-prescription-drug-markets.pdf Accessed 12 Jan 2026."},{"key":"961_CR5","unstructured":"\u201cAssessing the biosimilar void in U.S.: Achieving sustainable levels of biosimilar competition.\u201d IQVIA February 3, 2025. Available from: https:\/\/www.iqvia.com\/insights\/the-iqvia-institute\/reports-and-publications\/reports\/assessing-the-biosimilar-void-in-the-us Accessed 20 Mar 2026."},{"key":"961_CR6","doi-asserted-by":"crossref","unstructured":"Caves RE, Whinston MD, Hurwitz MA. \u201cPatent expiration, entry, and competition in the U.S. pharmaceutical industry.\u201d Brookings Papers: Microeconomics 1991. Available from: https:\/\/www.brookings.edu\/wp-content\/uploads\/1991\/01\/1991_bpeamicro_caves.pdf Accessed 12 Jan 2026.","DOI":"10.2307\/2534790"},{"key":"961_CR7","unstructured":"\u201cHow increased competition from generic drugs has affected prices and returns in the pharmaceutical industry.\u201d Congressional budget office July 1998. 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Milbank Q. 2021;99(3):828\u201352. https:\/\/doi.org\/10.1111\/1468-0009.12517.","journal-title":"Milbank Q"},{"issue":"2","key":"961_CR10","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1257\/jep.20241420","volume":"39","author":"RM Conti","year":"2025","unstructured":"Conti RM, Wosi\u0144ska ME. The economics of generic drug shortages: the limits of competition. J Econ Perspect. 2025;39(2):79\u2013102.","journal-title":"J Econ Perspect"},{"key":"961_CR11","unstructured":"\u201cU.S. Biosimilar market entry challenges and facilitating factors final report.\u201d Eastern Research Group August 18, 2025. Available from: https:\/\/aspe.hhs.gov\/sites\/default\/files\/documents\/2d5c0a194c180b52d1c760d3bb09f70a\/Biosimilars%20Final%20Report_250825_v508.pdf Accessed 12 Jan 2026."},{"key":"961_CR12","unstructured":"Lewin T. \u201cDrugmakers fighting back against advance of generics.\u201d The New York Times July 28, 1987. Available from: https:\/\/www.nytimes.com\/1987\/07\/28\/business\/drug-makers-fighting-back-against-advance-of-generics.html"},{"issue":"4","key":"961_CR13","doi-asserted-by":"publisher","first-page":"704","DOI":"10.1080\/19420862.2017.1305530","volume":"9","author":"S Kim","year":"2017","unstructured":"Kim S, Song J, Park S, Ham S, Paek K, Kang M, et al. Drifts in ADCC-related quality attributes of Herceptin\u00ae: Impact on development of a trastuzumab biosimilar. MAbs. 2017;9(4):704\u201314. https:\/\/doi.org\/10.1080\/19420862.2017.1305530.","journal-title":"MAbs"},{"key":"961_CR14","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.ejca.2019.07.015","volume":"120","author":"X Pivot","year":"2019","unstructured":"Pivot X, Pegram M, Cortes J, L\u00fcftner D, Lyman GH, Curigliano G, et al. Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer. Eur J Cancer. 2019;120:1\u20139. https:\/\/doi.org\/10.1016\/j.ejca.2019.07.015.","journal-title":"Eur J Cancer"},{"issue":"4","key":"961_CR15","doi-asserted-by":"publisher","first-page":"e250406","DOI":"10.1001\/jamahealthforum.2025.0406","volume":"6","author":"Y Kwon","year":"2025","unstructured":"Kwon Y, Sarpatwari A, Dusetzina SB. State substitution laws and uptake of an interchangeable insulin biosimilar. JAMA Health Forum. 2025;6(4):e250406. https:\/\/doi.org\/10.1001\/jamahealthforum.2025.0406.","journal-title":"JAMA Health Forum"},{"issue":"5","key":"961_CR16","doi-asserted-by":"publisher","first-page":"742","DOI":"10.1016\/j.jval.2025.02.008","volume":"28","author":"M Jofre-Bonet","year":"2025","unstructured":"Jofre-Bonet M, McGuire A, Dayer V, Roth JA, Sullivan SD. The price effects of biosimilars in the United States. Value Health. 2025;28(5):742\u201350. https:\/\/doi.org\/10.1016\/j.jval.2025.02.008.","journal-title":"Value Health"},{"issue":"10","key":"961_CR17","doi-asserted-by":"publisher","first-page":"e0292231","DOI":"10.1371\/journal.pone.0292231","volume":"18","author":"TM Herndon","year":"2023","unstructured":"Herndon TM, Ausin C, Brahme NN, Schrieber SJ, Luo M, Andrada FC, et al. Safety outcomes when switching between biosimilars and reference biologics: a systematic review and meta-analysis. PLoS ONE. 2023;18(10):e0292231. https:\/\/doi.org\/10.1371\/journal.pone.0292231.","journal-title":"PLoS ONE"},{"key":"961_CR18","unstructured":"\u201cClinical immunogenicity considerations for biosimilar and interchangeable insulin products.\u201d U.S. F.D.A. Draft Guidance November 2019. Available from: https:\/\/www.fda.gov\/media\/133014\/download Accessed 23 Jan 2026."},{"key":"961_CR19","unstructured":"\u201cConsiderations in demonstrating interchangeability with a reference product.\u201d U.S. F.D.A. Draft Guidance June 2024. Available from: https:\/\/www.fda.gov\/media\/179456\/download Accessed 23 Jan 2026."},{"key":"961_CR20","unstructured":"\u201cScientific considerations in demonstrating biosimilarity to a reference product: updated recommendations for assessing the need for comparative efficacy studies.\u201d U.S. F.D.A. Draft Guidance October 2025. Available from: https:\/\/www.fda.gov\/media\/189366\/download Accessed 23 Jan 2026."},{"key":"961_CR21","unstructured":"S.1954 - Biosimilar Red Tape Elimination Act. https:\/\/www.congress.gov\/bill\/119th-congress\/senate-bill\/1954\/cosponsors Accessed 23 Jan 2026."},{"key":"961_CR22","unstructured":"S.1414 - Expedited Access to Biosimilars Act. https:\/\/www.congress.gov\/bill\/119th-congress\/senate-bill\/1414\/text Accessed 23 Jan, 2026."}],"container-title":["Therapeutic Innovation &amp; Regulatory Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00961-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s43441-026-00961-9","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s43441-026-00961-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T13:49:50Z","timestamp":1783691390000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s43441-026-00961-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,7]]},"references-count":22,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["961"],"URL":"https:\/\/doi.org\/10.1007\/s43441-026-00961-9","relation":{},"ISSN":["2168-4790","2168-4804"],"issn-type":[{"value":"2168-4790","type":"print"},{"value":"2168-4804","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,7]]},"assertion":[{"value":"23 January 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 March 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"7 April 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Dr. Miller reports serving as a Commissioner on the Medicare Payment Advisory Commission and on the Board of Trustees for the North Carolina State Health Plan. He reports unrelated fees from the Advancing a Healthier Wisconsin Endowment, American Medical Association, Cato Institute, Dahlia Enterprises, Hoover Institution, and the Large Urology Group Practice Association. Dr. Miller reports unrelated grant support from the Ohio State University Drug Enforcement and Policy Center and Stand Together Trust. Dr. Woodcock reports serving on the board for the Alliance for Aging Research, Breakthrough Type 1 Diabetes, Clinical Trial Access Collaborative, EveryCure, Friends of Cancer Research, Haystack Project, Mila\u2019s Miracle Foundation, Quantum Leap Healthcare Collaborative, and Uncommon Cures. She reports consulting agreements with Sonoma Bio, Mahzi, BIO, Renovion, RA Capital, St. Judes, Rheumatologics, Intrabio.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}