{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,24]],"date-time":"2026-06-24T09:19:50Z","timestamp":1782292790524,"version":"3.54.5"},"reference-count":0,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2022,2,22]],"date-time":"2022-02-22T00:00:00Z","timestamp":1645488000000},"content-version":"vor","delay-in-days":52,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"FDA Sentinel Initiative"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:p>Neovascular age-related macular degeneration (AMD) is a progressive eye disease and is a leading cause of vision loss in the Western world. Vascular endothelial growth factor inhibitors have become a mainstay of treatment for this disease. Currently, treatment options include three originator biologics with approvals for neovascular AMD (aflibercept, ranibizumab, and brolucizumab-dbll) and one biologic that is commonly used off-label for the condition (bevacizumab). In the USA, Medicare spending on these drugs consistently surpassed $4 billion per year between 2015 and 2019, driven by high prices and varying off-label use of bevacizumab, which is substantially cheaper than the other biologics used to treat neovascular AMD. In this article, we discuss how legal reform can improve market competition for biologic drugs, using AMD therapies as a case study. We chose this group of drugs for their significant contribution to Medicare spending, the price difference between approved therapies and intravitreal bevacizumab, and because there currently exists a large biosimilar pipeline with many drug candidates in the final stage of development. We propose mechanisms for anticipating and facilitating the market introduction of biosimilars, as well as changes to the pricing model in Medicare that can promote use of cost-effective therapies. Reforms such as empowering Medicare to negotiate drug prices may help ensure that introduction of new biologics and biosimilars for AMD will lower spending and increase patient access.<\/jats:p>","DOI":"10.1093\/jlb\/lsac001","type":"journal-article","created":{"date-parts":[[2022,1,5]],"date-time":"2022-01-05T04:10:28Z","timestamp":1641355828000},"source":"Crossref","is-referenced-by-count":6,"title":["Competition law and pricing among biologic drugs: the case of VEGF therapy for retinal diseases"],"prefix":"10.1093","volume":"9","author":[{"given":"Victor L","family":"Van de Wiele","sequence":"first","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maximilian","family":"Hammer","sequence":"additional","affiliation":[{"name":"Institute of Physiology and Pathophysiology, Heidelberg University, Heidelberg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravi","family":"Parikh","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology and Visual Sciences, New York University School of Medicine, New York, NY, USA"},{"name":"Manhattan Retina and Eye Consultants, New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William B","family":"Feldman","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ameet","family":"Sarpatwari","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron S","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital and Harvard Medical School, Boston, MA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,2,22]]},"container-title":["Journal of Law and the Biosciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jlb\/article-pdf\/9\/1\/lsac001\/42577474\/lsac001.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jlb\/article-pdf\/9\/1\/lsac001\/42577474\/lsac001.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,22]],"date-time":"2022-02-22T20:29:14Z","timestamp":1645561754000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jlb\/article\/doi\/10.1093\/jlb\/lsac001\/6534392"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,1]]},"references-count":0,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2022,1,1]]}},"URL":"https:\/\/doi.org\/10.1093\/jlb\/lsac001","relation":{},"ISSN":["2053-9711"],"issn-type":[{"value":"2053-9711","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2022,1]]},"published":{"date-parts":[[2022,1,1]]},"article-number":"lsac001"}}