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In its recent Amgen Inc. v. Sandoz Inc. decision, the Federal Circuit decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). First, the Court held that the BPCIA does not require a biosimilar applicant to disclose its abbreviated biologics license application (“aBLA”) and manufacturing information to the reference product sponsor (“RPS”). Second, the Court concluded that the BPCIA does require the biosimilar applicant to provide notice of commercial marketing to the RPS. However, effective notice of commercial marketing can only be given after the United States Food & Drug Administration (“FDA”) licenses the aBLA product. This decision provides some of the first insight into how the Federal Circuit will, to quote Judge Lourie, “unravel the riddle, solve the mystery, and comprehend the enigma” that is the BPCIA.

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Alicia Russo has extensive experience litigating and prosecuting biologics, biotechnology, bioinformatics and pharmaceutical patents. She has a B.S. in Biology and Chemistry, and an M.S. in Biomedical Sciences. Alicia has published original papers in Science, Nature, Cell and the Proceedings of the National Academia of Sciences.

Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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