Udencya approved by FDA for neutropenia.- Coherus BioSciences.
Coherus BioSciences announced that the FDA has approved Udencya (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy. The European Commission approved the drug on September 21, 2018.
Udencya is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
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