FDA Approves Pegfilgrastim Biosimilar for Cancer

New Drug Reduces Infection in Chemotherapy Patients

The FDA has approved Udenyca (pegfilgrastim-cbqv, Coherus BioSciences, Redwood City, California) for patients with cancer who are receiving myelosuppressive chemotherapy. Pegfilgrastim-cbqv is a leukocyte growth factor designed to reduce infections as indicated by febrile neutropenia.

The drug is contraindicated for patients who have a history of serious allergic reaction to human granulocyte colony-stimulating factors and is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

The most common adverse reactions associated with pegfilgrastim-cbqv are bone pain and pain in extremities.

Pegfilgrastim-cbqv is Coherus’ first drug to receive approval from the FDA and has also been approved for use in Europe after receiving a favorable response from the European Medicines Agency’s Committee for Human Use in July of this year.

Source: GlobeNewswire, November 5, 2018; Healio.com, November 5, 2018