FDA Advisory Committee recommends approval of Pfizer's proposed biosimilar to Epogen® / Procrit® across all indications

PfizerPfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company's proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a U.S. FDA Advisory Committee.

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).[1]

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.

Pfizer Inc.: Working together for a healthier world®
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us.

1. Epogen® is a registered U.S. trademark of Amgen Inc.; Procrit® is a registered U.S. trademark of Johnson & Johnson

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