4:16 PM
May 15, 2018
 |  BC Extra  |  Company News

FDA approves Pfizer's Retacrit, first epoetin alfa biosimilar in U.S.

FDA approved Retacrit epoetin alfa-epbx from Pfizer Inc. (NYSE:PFE), a biosimilar of anemia drugs Epogen from Amgen Inc. (NASDAQ:AMGN) and Procrit from the Janssen Biotech Inc. unit of Johnson & Johnson (NYSE:JNJ). FDA said it is the first approved biosimilar of epoetin alfa, an agonist of the erythropoietin (EPO) receptor, in the U.S.

Pfizer said the approval covers all of Retacrit's reference products' indications. Those include anemia due to chronic kidney disease (CKD), use of zidovudine in HIV-infected patients and effects of concomitant myelosuppressive chemotherapy, and upon initiation, a minimum of two additional months of planned chemotherapy. The biosimilar is also approved to reduce allogeneic red blood cell transfusions in patients undergoing elective, non-cardiac, non-vascular surgery.

Pfizer plans to launch Retacrit this year. The pharma declined to disclose its price, but said the drug will be offered at a "significant discount" compared to the wholesale acquisition cost (WAC) of Epogen and Procrit. The WAC for 2 ml of 10,000 units/ml of Epogen is $331.60. For Procrit, the WAC for the same dose is $514.43.

Retacrit was approved in the EU in 2007, and Pfizer has marketed the product in more than 30 countries across Europe and Asia since 2008. The pharma noted that European Retacrit is a biosimilar to Eprex/Erypo epoetin alfa and “is comparable, but not equivalent to, U.S. Retacrit.”

Pfizer declined to disclose the drug's European sales. Citing IQVia, Pfizer said the erythropoetin stimulating agent (ESA) biosimilar market penetration in Europe has reached 51%.

In 2017, Amgen reported annual U.S. revenues of $1.1 billion for Epogen. For the same period, J&J reported Procrit sales of $675 million in the U.S. and worldwide sales of $297 million.

Pfizer gained Retacrit through its 2015 acquisition of Hospira Inc.

Amgen was off $3.62 to $172.34 on Tuesday.

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