EU agency accepts Sandoz application for pegfilgrastim biosimilar

[February 11, 2016]  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)

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