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FDA denies Amgen's biosimilar Citizen's Petition

March 28, 2015 1:50 AM UTC

FDA denied a Citizen's Petition from Amgen Inc. (NASDAQ:AMGN) asking the agency to require that biosimilar applications include a certification that the applicant will comply with the patent resolution protocol outlined in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Amgen submitted the petition in October after it filed a lawsuit against the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) to prevent the launch of Zarxio filgrastim-sndz, a biosimilar version of Amgen's Neupogen filgrastim G-CSF (see BioCentury Extra, Nov. 3, 2014).

Janet Woodcock, director of FDA's Center for Drug Evalation and Research, wrote in a letter to Amgen's attorneys that the BPCIA patent resolution protocol is "parallel to, but separate from, the FDA review process" and noted that the BPCIA does not require FDA "to impose a certification requirement as part of the biosimilar review process." The agency said interpretation of the BPCIA may be clarified by ongoing litigation. ...