Pfizer’s Epoetin Alfa Biosimilar Approved by FDA
The US Food and Drug Administration (FDA) on Tuesday approved the first biosimilar to Amgen’s blockbuster Epogen/Procrit (epoetin alfa), bringing the total number of biosimilars approved by the agency to 10.The biosimilar, called Retacrit (epoetin alfa-epbx), will be marketed by Pfizer’s Hospira unit and is approved for the same indications as Epogen/Procrit, including treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients with an HIV infection, and for use before and after surgery to reduce the need for red blood cell transfusions.
The approval comes after FDA rejected Pfizer’s application for Retacrit in June 2017 citing issues raised in a warning letter sent to the company’s McPherson, Kansas facility following a 2016 inspection. While that facility was listed as a potential manufacturing site on the biologics license application (BLA) for Retacrit, Pfizer said the issues in the warning letter did not specifically relate to manufacturing Retacrit.
Retacrit was approved in the EU in 2007 where it is marketed by Hospira UK Limited.
In addition to being approved for the same indications as its reference product, Retacrit also carries a boxed warning for increased risk of death, heart problems, stroke and tumor growth or recurrence and must be dispensed with a medication guide discussing those risks.
As with all previous biosimilars approved in the US, Retacrit is not approved as interchangeable with its reference product.
Pfizer has said it will market Retacrit at a “significant discount” compared to the current wholesaler acquisition cost for Epogen/Procrit but has declined to cite a specific price for the biosimilar.
FDA, Pfizer