Biosimilars Can't Circumvent BPCIA With Litigation

Law360, New York (December 13, 2013, 2:59 PM EST) -- The United States District Court for the Northern District of California ruled on Nov. 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) by obtaining a declaratory judgment of patent invalidity before even submitting a biosimilars application. See Sandoz Inc. v. Amgen Inc., Civil No. 13-2894 MMC, (N.D. Cal. 2013).

Biosimilars are follow-on products that reference an approved biologic product (a “Reference Product” or “RP”)...
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