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EU agency accepts Sandoz application for pegfilgrastim biosimilar

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)


The post EU agency Accepts Sandoz Application for pegfilgrastim biosimilar appeared first on GoodScout Insurance Aggregator | Your Go-To Guide To do-Good Insurance.

This post first appeared on The GoodScout Insurance Blog | Insurance Tips A, please read the originial post: here

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EU agency accepts Sandoz application for pegfilgrastim biosimilar


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