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
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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
