FDA approved Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim).

  • November 6, 2018

After previous US regulatory setbacks, Coherus Biosciences has gained FDA approval for its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv).

The biosimilar, referencing Neulasta, has been approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients receiving myelosuppressive chemotherapy associated with a clinically significant incidence of febrile neutropenia.

The company will provide more details on pricing and a launch date on its November 8 earnings call.

Udenyca joins 1 other pegfilgrastim biosimilar in the ranks of United States approvals; Mylan’s Fulphila is also approved, and launched, in the US market.

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