Pfizer has provided an update on its biologics licence application (BLA) for its proposed epoetin alfa biosimilar after receiving a complete response letter (CRL) from the US Food and Drug Administration (FDA).
Update
The CRL relates to issues raised in a warning letter the company received in February this year concerning Pfizer’s facility in McPherson, Kansas, which was listed as the potential manufacturing site for the proposed biosimilar in the BLA. The warning letter was sent relating to the site and not specifically the manufacture of the biosimilar.
In a release, Pfizer stated that it had submitted a corrective and preventative action plan to the FDA back in March and has been working to address the items outlined in the warning letter. It specified that it has been providing regular updates to the FDA on the status of this action plan and is dedicated to addressing the FDA’s concerns raised about the McPherson site.
A recommendation for the submission for approval of the biosimilar was given by an Oncologic Drugs Advisory Committee (ODAC) after a vote in May. This recommendation was made in part as a result of the FDA’s briefing materials, which concluded that the proposed biosimilar, epoetin alfa, is highly similar to its reference product, Epogen and Procrit, and supports a demonstration that there are no clinically meaningful differences in terms of the safety, purity and potency of the product.
Additional clinical data was not requested in the CRL at this time to support a future approval.