Pfizer has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its biologics license application (BLA) for its proposed epoetin alfa biosimilar over manufacturing issues.

The CRL relates to matters noted in a Warning Letter issued on February 14, 2017 following a routine FDA inspection of the company’s facility in McPherson, Kansas in 2016. This facility was listed as the potential manufacturing site in the BLA for the proposed epoetin alfa biosimilar. The issues noted in the Warning Letter do not relate specifically to the manufacture of epoetin alfa, noted Pfizer in a company statement. No additional clinical data were requested in the CRL at this time to support a future approval.

In May 2017, the FDA Oncologic Drugs Advisory Committee (ODAC) voted to recommend Pfizer’s proposed biosimilar for approval. Pfizer noted that the ODAC’s recommendation was based, in part, on the FDA’s briefing materials, which concluded that the proposed biosimilar epoetin alfa was highly similar to its reference product, Epogen and Procrit (epoetin alfa), and supports a demonstration that there are no clinically meaningful differences in terms of the safety, purity, and potency of the product. The reference products, Amgen’s Epogen and Johnson & Johnson’s Procrit/Eprex, had 2016 sales respectively of $1.28 billion and $1.1 billion. 

Pfizer submitted a corrective and preventative action plan to the FDA in March 2017 and said it has been working to address the items outlined in the Warning Letter. Pfizer further noted that it provides regular updates to FDA on the status of its action plan and that it remains dedicated to addressing all of FDA’s concerns with the McPherson site.

Source: Pfizer