March 14, 2016 Articles

Unanswered Issues in the Federal Circuit's Amgen v. Sandoz Decision

Although the Federal Circuit declined to rehear the case, lower courts are beginning to address unresolved issues regarding biosimilars

By Ronald C. Kern Jr.

Less than two months after the U.S. Court of Appeals for the Federal Circuit issued a divided decision regarding biosimilars and the Biologics Price Competition and Innovation Act (BPCIA) in Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), Sandoz (a subsidiary of Novartis AG) launched ZarxioTM, the first ever biosimilar product approved in the United States. The Federal Circuit's decision was its first (and to date only) analysis of the BPCIA but, as the Federal Circuit subsequently declined to rehear the case, many unresolved issues that will significantly affect the biologics industry linger.

The Biologics Price Competition and Innovation Act

The BPCIA, which creates an abbreviated licensure pathway for similar versions of previously approved biologics, was signed into law on March 23, 2010, as part of the Affordable Care Act, codified at 42 U.S.C. section 262. To obtain approval of a "biosimilar" under the act, the subsection (k) applicant must submit an abbreviated biologics license application (aBLA) demonstrating that its product is, among other things, "highly similar" to the approved reference product. Key among the provisions of the BPCIA are the information exchange (the "patent dance"; 42 U.S.C. § 262(l)(2)–(7)) and notice of commercial marketing (42 U.S.C. § 262(l)(8)(A)) provisions, both of which were at the heart of the Federal Circuitdecision in Amgen.

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