22 June 2017 - Pfizer today announced that it has received a complete response letter from the U.S. FDA regarding the company’s biologics license application for its proposed epoetin alfa biosimilar. 

This letter relates to matters noted in a warning letter issued on 14 February 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 application for the proposed epoetin alfa biosimilar. 

The issues noted in the warning letter do not relate specifically to the manufacture of epoetin alfa.

Read Pfizer press release