Novartis Withdraws European Application for Biosimilar

Novartis has withdrawn its marketing authorization application (MMA) with the European Medicines Agency (EMA) for its biosimilar candidate to Amgen’s Neulasta (pegfilgrastim), a drug for inducing white blood cell production in cancer patients. Neulasta is one of Amgen’s top-selling drugs with 2016 sales of $4.6 billion.

Novartis had submitted the MMA for its biosimilar, Zioxtenzo (pegfilgrastim), seeking approval for treating neutropenia in cancer patients. Based on a review of the data submitted in the MMA, The Committee for Medicinal Products for Human Use (CHMP) of the EMA raised two concerns pertaining to studies not showing that Zioxentzo was “highly similar” to Neulasta and the need for an inspection of the manufacturing site in the absence of a GMP certificate.

The EMA stated that Novartis’ letter notifying the agency of its application withdrawal stated that the company would not be able to provide the additional data required by the CHMP within the time frame allowed.

Soure: European Medicines Agency 

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