FDA clears Pfizer's Retacrit as a biosimilar of Amgen's Epogen, Johnson & Johnson's Procrit

The FDA on Tuesday authorised Pfizer's Retacrit (epoetin alfa-epbx) as a biosimilar version of Amgen's Epogen (epoetin alfa) and Johnson & Johnson's Procrit (epoetin alfa) for treating anaemia due to chronic kidney disease, chemotherapy or treatment with zidovudine in patients with HIV infection. The biosimilar was also authorised for use before and after surgery to reduce the need for red blood cell transfusions due to blood loss during surgery. Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff in the FDA's Center for Drug Evaluation and Research, commented "it is important for patients to have access to safe, effective and affordable biological products and we are committed to facilitating the development and approval of biosimilar and interchangeable products."  

Approval of Retacrit, which Pfizer said marks the first authorisation of an epoetin alfa biosimilar in the US, comes after the FDA issued a complete response letter to the company's filing last year despite a positive recommendation by an FDA advisory panel. The agency explained that its decision to approve the drug was based on a review of data, including extensive structural and functional characterisation, human pharmacokinetic and pharmacodynamic data and clinical immunogenicity data, demonstrating the biosimilarity of the drug to Epogen and Procrit.  

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Although Pfizer did not provide information regarding pricing, the drugmaker indicated that it expects Retacrit to be offered at a "significant discount" to the current wholesale costs of Epogen and Procrit. The company separately announced a partnership with Vifor Pharma regarding commercialisation of the therapy in certain channels.

Amgen generated $1.1 billion in revenue for Epogen in 2017, reflecting approximately 5 percent of its total revenue, while Johnson & Johnson recorded $972 million in sales for Procrit during the same period. 

Pfizer gained rights to Retacrit as part of its 2015 takeover of Hospira. 

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