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EU agency accepts Sandoz application for pegfilgrastim biosimilar
February 11, 2016 / 6:45 AM / in 2 years

EU agency accepts Sandoz application for pegfilgrastim biosimilar

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.

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

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

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