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Pfizer gets FDA Complete Response Letter on biosimilar

June 24, 2017

Pfizer Inc. (NYSE: PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in a Warning Letter issued on February 14, 2017 following a routine Agency 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.

No additional clinical data was requested in the CRL at this time to support a future approval.

An Oncologic Drugs Advisory Committee (ODAC) voted on May 25, 2017 to recommend this proposed biosimilar for approval. The ODAC’s recommendation was based, in part, on the FDA’s briefing materials, which concluded that proposed biosimilar epoetin alfa is highly similar to its reference product, Epogen® and Procrit® (epoetin alfa)1, and supports a demonstration that there are no clinically meaningful differences in terms of the safety, purity and potency of the product2.

Pfizer submitted a corrective and preventative action plan to the FDA in March 2017, and has been diligently working to address the items outlined in the Warning Letter. Pfizer provides regular updates to FDA on the status of its action plan, and remains dedicated to addressing all of FDA’s concerns with the McPherson, KS site. The company is committed to making this important treatment option available to patients and physicians as quickly as possible.


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