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Pharmaceuticals / Submissions and Approvals

FDA Grants Approval to Coherus’ Febrile Neutropenia Biosimilar

Nov. 12, 2018

The FDA approved Coherus BioScience’s Udenyca for treating febrile neutropenia, making it the agency’s first approval for a Neulasta (pegfilgrastim) biosimilar.

The biosimilar is used for treating the onset of fever and other symptoms of infection in patients with an abnormally low number of neutrophil granulocytes in their blood.

Udenyca is taken subcutaneously using a single 6 mg dose from a prefilled syringe designed for manual use. The agency noted that serious allergic reactions, including anaphylaxis, can occur in patients that use pegfilgrastim products.

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