EU agency accepts Sandoz application for pegfilgrastim biosimilar

Reuters
The logo of Swiss pharmaceutical company Novartis is seen at the company's plant in Hueninge, France January 27, 2016. REUTERS/Arnd Wiegmann

ZURICH (Reuters) - The European Medicines Agency (EMA) has accepted an application to review Sandoz's biosimilar to Amgen's EU-licensed Neulasta (pegfilgrastim), a recombinant human granulocyte colony-stimulating factor, Sandoz parent Novartis said on Thursday. Sandoz is seeking approval for the same indication as the reference product, it added in a statement. The U.S. Food and Drug Administration in November accepted Sandoz's submission for approval of a biosimilar version of Amgen's Neulasta drug that fights infections in cancer patients. (Reporting by Michael Shields)