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

Pfizer begins a Phase 1/2 study to evaluate respir…

Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1/2 trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adult volunteers. RSV i...

Eczema drug effective against severe asthma

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients' ability to breathe bett...

Most popular vitamin and mineral supplements provi…

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital...

AstraZeneca heads to 2018 ASCO Annual Meeting with…

AstraZeneca and MedImmune, its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US...

Tiny particles could help fight brain cancer

Glioblastoma multiforme, a type of brain tumor, is one of the most difficult-to-treat cancers. Only a handful of drugs are approved to treat glioblastoma, and the median ...

Novartis data at ASCO and EHA reinforce company's …

Novartis will present data from across its oncology portfolio at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 1-5 ...

Spiolto® Respimat® enables greater physical activi…

Boehringer Ingelheim announced data which add to the growing body of evidence that show Spiolto® (tiotropium/olodaterol) Respimat® enables greater physical activity in pa...

New approach to immunotherapy leads to complete re…

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was...

Amgen Foundation and Harvard team up to offer free…

The Amgen Foundation and Harvard University today announced plans to launch a free online science education platform uniquely designed to level the playing field for aspi...

Study demonstrates new treatment for severe asthma

Researchers from McMaster University and the Firestone Institute for Respiratory Health at St. Joseph's Healthcare Hamilton, together with colleagues at other partnering ...

The Pfizer Foundation announces $5 million in gran…

The Pfizer Foundation announced a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for...

Study finds antioxidant-enriched vitamin reduces r…

Researchers at Children's Hospital Colorado (Children's Colorado) and the University of Colorado School of Medicine have found that taking a specially formulated antioxid...