Pfizer Gets FDA Advisory Committee Nod for Biosimilar

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First biosimilar erythropoiesis-stimulating agent (ESA) to receive a recommendation for approval. The United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has recommended that Pfizer Inc.’s proposed Epoetin alfa biosimilar be approved across all indications. The recommendation for approval is the first for a biosimilar erythropoiesis-stimulating agent (ESA) by a U.S. FDA Advisory Committee.

A human erythropoietin, epoetin alfa stimulates red blood cell production and is mainly intended for the treatment of anemia that occurs along with chronic kidney failure and chemotherapy. It is manufactured via cell culture using recombinant DNA technology.

Pfizer is seeking FDA approval for the treatment of anemia due to Chronic Kidney Disease (CKD) in patients both on and not on dialysis, Zidovudine in HIV-infected patients and 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 is an additional indication for which the company is seeking approval.

The positive recommendation was reached by the committee after considering the totality of evidence, including the demonstration of comparable efficacy and safety of biosimilar epoetin alfa to its reference products, Epogen® and Procrit® (epoetin alfa).[1]

“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.”

Although FDA is not required to approve drugs that receive positive recommendations, it typically does. In preparation for receipt of approval for its Biologics License Application (BLA) for the proposed epoetin alfa biosimilar across all indications, Pfizer has established an agreement with Vifor Pharma Inc., which will commercialize the proposed epoetin alfa biosimilar in certain channels.

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


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.