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FDA Approves Neulasta Biosimilar for Recipients of Myelosuppressive Chemo
The FDA has approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences) as a biosimilar to pegfilgrastim (Neulasta; Amgen) for use in reducing rates of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy associated with a clinically significant rate of febrile neutropenia.
Pegfilgrastim-cbqv, a pegylated growth colony-stimulating factor, is the first pegfilgrastim biosimilar to be approved by the FDA and the European Commission.
“The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the US. We believe that competition is essential in controlling burdensome price increases, and UDENYCA will play an important role in curbing that spend when launched,” said Dennis M. Lanfear, President, CEO, and Chairman, Coherus BioSciences, in a press release.
This approval was based on a review of evidence, including a comprehensive analytical similarity package, and data regarding pharmacokinetics, pharmacodynamics, and immunogenicity demonstrating that pegfilgrastim-cbqv is a biosimilar to the reference drug.
“UDENYCA’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” said Barbara Finck, MD, Chief Medical Officer, Coherus BioSciences, in the press statement.
“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,” she added.
The most common adverse reactions associated with pegfilgrastim-cbqv are bone and extremity pain.—Janelle Bradley
