There are currently only two biosimilars on the market in the US in contrast to the 21 biosimilars have been approved in Europe since 2006.Â Part of the reason for the lack of biosimilars is that until recently, there has been no abbreviated pathway for a biosimilar to reach the market meaning that biosimilars had to undergo the long and costly process of obtaining approval just like an innovator biologic product. After years of negotiation, however, the Biologics Price Competition and Innovation Act (the â€œBiosimilars Actâ€) was signed into law on March 23, 2010, by President Obama as Title VII of the Patent Protection and Affordable Care Act.Â The Biosimilars Act established an abbreviated pathway by which the FDA could approve generic versions of previously licensed biological products. The Biosimilars Act sets forth several requirements for biosimilar applications, including the so-called â€œPatent Danceâ€ which describes the process by which the biosimilar applicant and the reference product sponsor (â€œRPSâ€) exchange patent-related information before the biosimilar can enter the market.Â In this article, we will explore what the Patent Dance is and what it means for biosimilars that are seeking market entry in the US.Â
Biosimilars approved in Europe, Generics and Biosimilars Initiative, (July 4, 2014), http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe.
42 U.S.C. Â§ 262(k).
Id. Â§ 262 (j)
Id. Â§ 262(l)
Id. Â§ 262(l)(2).
Id. Â§ 262(l)(3)(A).
Id. Â§ 262(l)(3)(B)(i).
Id. Â§ 262(l)(3)(B)(ii).
Id. Â§ 262(l)(3)(C).
Id. Â§ 262(l)(4).
Id. Â§ 262(l)(6)(A).
Id. Â§ 262(l)(5)(A).
Id. Â§ 262(l)(5)(B)(ii)(II).
Id. Â§ 262(l)(6)(B).
Id. Â§ 262(l)(8)(A).
Id. Â§ 262(l)(8)(B).
Id. Â§ 262(l)(7).
Id. Â§ 262(l)(9)(B).
Id. Â§ 262(l)(9)(A).
FDA accepts Sandoz application for biosimilar filgrastim, Novartis, (July 24, 2014, 07:15 CET), http://www.novartis.com/newsroom/media-releases/en/2014/1835571.shtml.
Celltrion files for US FDA approval of RemsimaÂ®, Celltrion, (Aug. 11, 2014), http://www.celltrion.com/en/COMPANY/notice_view.asp?idx=456&code=ennews&intNowPage=1&menu_num=&align_year=all
Johnson & Johnson, Annual Report (Form 10-K Ex. 13) at 5 (Feb. 21, 2014).
See Sandoz Inc. v. Amgen Inc., C-13-2904 MMC, 2013 WL 6000069, at *1 (N.D. Cal. Nov. 12, 2013), appeal docketed, No. 14-1693 (Fed. Cir.) (Dec. 13, 2013).
Id. at *2.
David A. Fazzolare, Gaming the Biosimilars Act: Loopholes Allow Authorized Interchangeable Settlement Agreements to Delay Authentic Generic Competition up to 18 Months, FDA UPDATE, July/August 2010.
Jack Deruiter & Pamela L. Holston, Drug Expirations and the â€œPatent Cliffâ€,US PHARMACIST SUPPLEMENTS GENERIC DRUG REVIEW, June 2012, at 12.
42 U.S.C. 262(k)(6)(C)(ii).
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