FDA Advisors Recommend Approval of Proposed Biosimilar to Epogen and Procrit

First biosimilar erythropoiesis-stimulating agent backed by an FDA panel

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval of a proposed epoetin alfa biosimilar (Pfizer) across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent has been recommended for approval by an FDA advisory committee.

The panel’s favorable recommendation was based on its review of the clinical data, including the demonstration of comparable efficacy and safety of biosimilar epoetin alfa to its reference products, Epogen (Amgen) and Procrit (Janssen).

Pfizer is seeking FDA approval of its epoetin alfa biosimilar for the treatment of anemia due to: 1) chronic kidney disease in patients on dialysis and not on dialysis; 2) zidovudine in patients with human immunodeficiency virus infection; and 3) the effects of concomitant myelosuppressive chemotherapy. Pfizer is also seeking approval of its biosimilar product for the reduction of allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

The FDA will take the committee’s recommendation into consideration before acting on the biologics license application for the proposed epoetin alfa biosimilar across all indications.

Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of its proposed epoetin alfa biosimilar in certain channels.

Source: Pfizer; May 25, 2017.