Amgen opens new front in biosimilar dispute with Sandoz

Amgen Inc. (NASDAQ:AMGN) added fuel on top of its lawsuit against the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) with a Citizen's Petition asking FDA 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). The petition asserts that without FDA action, "the risk of non-compliance is real and substantial."

BPCIA stipulates that a biosimilar applicant provide the reference product sponsor with a copy of the BLA and manufacturing information for its biosimilar within 20 days of FDA's acceptance of the application for review. The procedure is designed to resolve any patent disputes before a biosimilar is approved and commercialized. ...