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Amgen, Novartis biosimilars news

November 10, 2014 8:00 AM UTC

Amgen submitted a Citizen's Petition to FDA asking the agency to require that biosimilar applications include a certification that the applicant will comply with patent resolution protocol of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Last month, Amgen filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Novartis' Sandoz Inc. generics unit has not followed statutory requirements related to their submission of a BLA to FDA for a biosimilar version of Amgen's neutropenia drug Neupogen filgrastim G-CSF. Amgen argues that Sandoz did not provide Amgen with the BLA and manufacturing information within 20 days of FDA's acceptance for review, as required under BPCIA (see BioCentury, Nov. 3).

In its Citizen's Petition, Amgen alleges that Sandoz said it views the patent resolution procedure as "optional." In a statement, the generics maker said "as Sandoz is the first company using the pathway to bring cost-effective biosimilars to market in the U.S., it is understandable that Amgen and Sandoz might take a different view of the BPCIA provisions." ...