FDA Approves First Pegfilgrastim Biosimilar for Patients Receiving Chemotherapy

By Cassie Homer
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The FDA approved Udenyca, the first pegfilgrastim biosimilar, for patients receiving myelosuppressive chemotherapy, according to the manufacturer.

Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils among patients undergoing chemotherapy to help them fight infection.

“The list price of Neulasta [pegfilgrastim] has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the US,” Denny Lanfear, chairman, CEO and president of Coherus BioSciences, said in a press release. “We believe that competition is essential in controlling burdensome price increases, and Udenyca will play an important role in curbing that spend when launched,”


FDA building lab. Source

Udenyca (pegfilgrastim-cbqv) — a PEGylated growth colony stimulating factor — is indicated to decrease incidence of infection manifested by febrile neutropenia among patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

The FDA based its approval on comprehensive analytical similarity analysis, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies..

“Udenyca’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” Barbara Finck, MD, chief medical officer of Coherus BioSciences, said in the release. “In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of Udenyca, but also advanced the understanding of the immunogenic response of pegfilgrastim products.”

Udenyca is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.