First Biosimilar for Epogen and Procrit Approved
May 15, 2018 – The U.S. FDA has approved Retacrit (epoetin alfa-epbx), manufactured by Pfizer. Retacrit is a biosimilar to Amgen’s Epogen® (epoetin alfa) and Janssen’s Procrit® (epoetin alfa). It is approved to treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. It is also indicated for use before and after surgery to reduce the chance that red blood cell transfusions will be needed due to blood loss during a procedure.
Due to the complex nature of biological products such as Epogen and Procrit, biosimilars such as Retacrit are not considered automatically interchangeable. They can, however, offer a highly similar alternative to their reference products. Retacrit is the first biosimilar available for epoetin alfa products.
Erythropoiesis-stimulating agents (ESAs) like Retacrit all carry a black box warning that they may increase the risk of death, myocardial infarction, stroke, venous thromboembolism, thrombosis of vascular access, and tumor progression or recurrence.
Pfizer plans to make Retacrit available in single-dose vials of multiple strengths: 2000 Units/mL, 3000 Units/mL, 4000 Units/mL, 10,000 Units/mL, and 40,000 Units/mL. The company will launch Retacrit before the end of 2018. Although a specific price has not yet been announced, Pfizer has announced it intends to price their biosimilar significantly lower than Epogen and Procrit.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.