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FDA Accepts for Review Sandoz’s Application for a Biosimilar of Amgen’s Enbrel

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review.  The acceptance comes years after Sandoz attempted to bypass the litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA).  In 2013, Sandoz sued Amgen and Hoffman-La Roche Inc. to obtain a declaratory judgment that two patents owned by Hoffman-La Roche and exclusively licensed to Amgen were invalid, unenforceable, and would not be infringed if Sandoz were to market a biosimilar of Amgen’s Enbrel.  Sandoz filed its suit long before submitting a regulatory application to FDA for marketing approval of its proposed biosimilar and therefore before litigation under the patent dispute resolution procedures of the BPCIA is possible.  At the time of the suit, Sandoz had only begun certain studies for its anticipated regulatory filing.  Nearly two years ago, the district court dismissed the case on two grounds: first, there was no justiciable case or controversy under the Declaratory Judgment Act and Article III of the Constitution, and second, Sandoz could not file a declaratory judgment action without first exhausting the BPCIA patent dispute resolution procedures.  The Federal Circuit affirmed on justiciability grounds, and expressly declined to address the BPCIA.  It remains to be seen whether Sandoz now will follow the BPCIA and provide its regulatory application and other manufacturing information to Amgen since the Federal Circuit has recently held that doing so is optional in Amgen v. Sandoz, another case involving the same parties and the Federal Circuit’s first decision to interpret the BPCIA.  Amgen is currently seeking en banc review of this ruling.

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