Pfizer’s Biosimilar RETACRIT® (epoetin alfa-epbx) Approved by U.S. FDA

Pfizer Inc. announced the United States FDA approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S.

“As the first approved epoetin alfa biosimilar in the U.S., RETACRIT may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients,” said Berk Gurdogan, U.S. Institutions President, Pfizer Essential Health. “We are proud of the progress of our biosimilars program to date, which will help address the evolving needs of patients and the broader healthcare community.”

The FDA approval was based on a comprehensive data package submitted by Pfizer demonstrating a high degree of similarity between RETACRIT and its U.S. reference product, Epogen and Procrit.2

In the U.S., RETACRIT is indicated for:3

    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.

“With the approval of RETACRIT, healthcare providers now have an additional option to choose from when prescribing an ESA,” said George M. Rodgers, M.D., Ph.D., Professor of Medicine, Division of Hematology and Hematologic Malignancies, Department of Internal Medicine, University of Utah School of Medicine. “By providing potentially more affordable therapeutic options, biosimilar medicines can allow for the reallocation of resources to other areas of cancer care. This is positive news for the oncology community.”

RETACRIT is expected to be available in the U.S. at a significant discount to the current wholesaler acquisition cost (WAC) of Epogen and Procrit. WAC is not inclusive of discounts to payers, providers, distributors and other purchasing organizations.

Pfizer has entered into an agreement with Vifor Pharma Inc. for the commercialization of RETACRIT in certain channels.

RETACRIT is Pfizer’s third approved biosimilar in the U.S. Pfizer’s biosimilars pipeline consists of 11 distinct biosimilar molecules with six assets in mid-to-late stage clinical development.4

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. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com

 

Reference:
1 Epogen® is a registered U.S. trademark of Amgen Inc.; Procrit® is a registered U.S. trademark of Johnson & Johnson
2 U.S. Food & Drug Administration, Oncologic Drugs Advisory Committee Meeting. (2017, May 23). ODAC Briefing Document: BLA 125545 for “Epoetin Hospira”, a proposed biosimilar to Epogen/Procrit. Retrieved from https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM559967.pdf
3 https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125545s000lbl.pdf
4 Pfizer. (2018, January 30). Pfizer pipeline. Retrieved from https://www.pfizer.com/sites/default/files/product-pipeline/01302018_PipelineUpdate.pdf

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