According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha). Pfizer said the 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.”  The aBLA identifies that facility as the potential manufacturing site for the proposed epoetin alfa biosimilar.  Pfizer said it submitted a corrective action plan to the FDA in March and has been working to address the items outlined in the Warning Letter.  Pfizer did not provide an estimate of when its aBLA would be resubmitted.

As we previously reported, Pfizer first resubmitted its aBLA in December 2016, and in late May, the FDA Oncologic Drugs Advisory Committee (“ODAC”) recommended approval of Pfizer’s proposed epoetin alfa biosimilar across all indications.