The Committee's favorable recommendation was based on its review of the totality of evidence, including demonstration of comparable efficacy and safety of biosimilar epoetin alfa to its reference product, Epogen® and Procrit® (epoetin alfa).
The company is seeking FDA approval of the following indications:
- Treatment of anemia due to:
- Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis.
- Zidovudine in HIV-infected patients.
- The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy.
- Reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
"The Committee's recommendation reinforces the potential value of biosimilars in expanding access to additional high-quality treatment options for the patients in the U.S. who need them," said Diem Nguyen, Global President, Americas, Pfizer Essential Health. "Following the approval and launch of INFLECTRA® (infliximab-dyyb) in 2016, this positive recommendation - a first for a proposed ESA biosimilar - marks an important milestone for Pfizer's U.S. biosimilars portfolio."
The FDA will take the Committee's recommendation into consideration before taking action on the Biologics License Application (BLA) 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.
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1. Epogen® is a registered U.S. trademark of Amgen Inc.; Procrit® is a registered U.S. trademark of Johnson & Johnson