FDA plans review of Sandoz's Neupogen biosimilar
FDA's Oncologic Drugs Advisory Committee will meet January 7 to discuss Sandoz's biologics license application for EP2006, a biosimilar version of Amgen's top-selling Neupogen (filgrastim) and the first ever biosimilar application when it was filed in July.
In October Amgen filed a citizens petition to FDA and a lawsuit alleging that Sandoz has failed to follow patent resolution procedures laid out in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). A California US district court has yet to rule on the filing.
Then earlier this week, a US appeals court dismissed a patent suit filed by Sandoz against Amgen and Roche pertaining to Sandoz's biosimilar Enbrel (etanercept). The court ruled that Sandoz prematurely filed the lawsuit as Sandoz has not yet filed for FDA approval of a biosimilar version of Enbrel, the Wall Street Journal reports.
Industry is closely following the litigation to see how the courts will interpret the BPCIA requirements which set forth “patent dance” information exchange procedures for resolving biosimilar patent challenges.
Novartis this week announced more supporting evidence in favor of its Neupogen knockoff which is used to decrease rates of infection in cancer patients undergoing chemotherapy. A Phase-III PIONEER study demonstrated the biosimilar had similar efficacy and safety compared with Neupogen and that repeated switching between the two at each cycle showed no impact on efficacy, safety or immunogenicity.