FDA Approves Second Filgrastim Biosimilar

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

Filgrastim-aafil is indicated for aiding in recovery from neutropenia in patients undergoing chemotherapy. It also is indicated for patients who are receiving myelosuppressive chemotherapy, those with acute
myeloid leukemia receiving induction or consolidation chemotherapy, those undergoing hematopoietic cell 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.

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.

Source: Medscape, July 20, 2018.