Udenyca, Second Biosimilar to Neulasta, FDA-Approved to Reduce Risk for Infection in Patients with Nonmyeloid Malignancies

December 2018, Vol 9, No 4 - FDA Approvals, News & Updates, Online First


On November 2, 2018, the FDA approved pegfilgrastim-cbqv (Udenyca; Coherus BioSciences), as the second biosimilar to pegfilgrastim (Neulasta), to reduce the risk for infection in patients with nonmyeloid malignancies who receive myelosuppressive chemotherapy, which may result in febrile neutropenia.

The approval of pegfilgrastim-­cbqv was based on a variety of studies confirming that it is a biosimilar to the reference drug Neulasta.

The most common (5%) adverse events with pegfilgrastim-­cbqv are bone pain and pain in extremities. Serious adverse events include aortitis, splenic rupture, acute respiratory distress syndrome, serious allergic reactions, glomerulonephritis, leukocytosis, and capillary leak syndrome.

Treatment with pegfilgrastim­cbqv may also cause fatal sickle-cell crisis in patients with sickle-cell disorders, stimulate tumor growth on malignant cells, and cause transient positive nuclear imaging changes because of increased hematopoietic activity of the bone marrow.