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

Most Popular Now

FDA approves Vosevi for Hepatitis C

The U.S. Food and Drug Administration has approved Vosevi to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mil...

Green tea ingredient may ameliorate memory impairm…

A study published online in The FASEB Journal, involving mice, suggests that EGCG (epigallocatechin-3-gallate), the most abundant catechin and biologically active compone...

New way found to boost immunity in fight cancer an…

An international research team led by Université de Montréal medical professor Christopher Rudd, director of research in immunology and cell therapy at Maisonneuve-Rosemo...

Amgen and Array BioPharma announce preclinical lic…

Amgen (NASDAQ:AMGN) and Array BioPharma (NASDAQ:ARRY) today announced a collaboration agreement for the discovery and development of novel drugs for autoimmune disorders...

Merck and Pfizer collaborate with Corning

Merck (NYSE: MRK), Pfizer (NYSE: PFE) and Corning Incorporated (NYSE: GLW) today announced collaborations that have enabled the modernization of pharmaceutical packaging ...

One minute of running per day associated with bett…

A single minute of exercise each day is linked to better bone health in women, new research shows. Scientists from the University of Exeter and the University of Leiceste...

Americans say discussions about clinical trials sh…

An overwhelming majority of Americans (86%) agree that health care professionals should discuss clinical trials with patients diagnosed with a disease as part of their st...

AstraZeneca and Merck establish strategic oncology…

AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) today announced that they have entered a global strategic oncology collaboration to ...

27 Phase III and 8 Phase II Alzheimer's drugs on t…

Twenty-seven Alzheimer's drugs in Phase III clinical trials and eight drugs in Phase II clinical trials may launch in the next five years, according to a revised Alzheime...

Johnson & Johnson announces encouraging first-…

Johnson & Johnson has announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Compani...

How physical exercise prevents dementia

Numerous studies have shown that physical exercise seems beneficial in the prevention of cognitive impairment and dementia in old age. Now researchers at Goethe Universit...

New drug may treat and limit progression of Parkin…

Researchers at Binghamton University have developed a new drug that may limit the progression of Parkinson's disease while providing better symptom relief to potentially ...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]