FDA Approves Biosimilar Udenyca for Patients Receiving Myelosuppressive Chemotherapy
The Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv; Coherus BioSciences), a biosimilar to Neulasta (Amgen), 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.
A biosimilar means that the product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product and that there are no clinically meaningful differences between the biosimilar and the reference product. "Udenyca's robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects,” said Barbara Finck, MD, Chief Medical Officer of Coherus BioSciences. “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 will be supplied as 6mg/0.6mL preservative-free solution in prefilled syringes for subcutaneous injection.
For more information visit Udenyca.com.