FDA Approves Udenyca, Second Biosimilar Pegfilgrastim

November 5, 2018

Biosimilars Team

The Food and Drug Administration (FDA) has approved Udenyca (pegfilgrastim-cbqv; Coherus BioSciences, Inc.), a biosimilar to pegfilgrastim (Neulasta; Amgen).

Udenyca is the second pegfilgrastim biosimilar.  Fulphila (pegfilgrastim-jmdb; Mylan) was approved in June 2018 and marketed in July 2018.

Pegfilgrastim is a leukocyte growth factor administered by subcutaneous injection to decrease the incidence of infection as manifested by febrile neutropenia (fever, often with other signs of infection, associated with an abnormally low number of infection-fighting white blood cells) in patients with non-myeloid (non-bone marrow) malignancies who are receiving myelosuppressive chemotherapy that has a clinically significant incidence of febrile neutropenia.  Detailed information about Udenyca is provided in the full prescribing information.

Udenyca is not approved as an interchangeable product.