FDA Approves Second Filgrastim Biosimilar

The U.S. Food and Drug Administration (FDA) has approved filgrastim-aafil, a biosimilar version of filgrastim, making it the second approved biosimilar for this agent. The treatment was given the same indications as filgrastim and is expected to be made available at a substantially lower cost than its reference biologic product.

Biosimilars are pharmaceutical products that are similar, but not identical, to biologics that have already received FDA approval. The FDA’s decision on filgrastim-aafil follows the 2015 approval of the biosimilar filgrastim-sndz and is based on evidence demonstrating its high degree of similarity to filgrastim.

Filgrastim-aafil is indicated for aiding in recovery from neutropenia in cancer patients undergoing chemotherapy treatment. It also is indicated for patients with cancer who are receiving myelosuppressive chemotherapy, those with acute myeloid leukemia receiving induction or consolidation chemotherapy, those undergoing bone marrow transplantation, and those undergoing autologous peripheral blood progenitor cell collection and therapy.

In clinical trials, the most common adverse events (AEs) associated with filgrastim and its biosimilar versions were pyrexia, pain, rash, cough, headache, epistaxis, and dyspnea. In patients with severe chronic neutropenia, AEs included pain, anemia, epistaxis, diarrhea, hypoesthesia, and alopecia.

Source: Medscape, July 20, 2018.