FDA Advisory Committee Recommends Approval of Pfizer’s EPOGEN®/PROCRIT® Biosimilar

Goodwin
Contact

As we previously reported, the FDA Oncologic Drugs Advisory Committee (“ODAC”) held a public meeting today regarding Hospira’s application for its proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa).  Pfizer, Hospira’s parent company, has announced today that ODAC recommended approval of their proposed epoetin alfa biosimilar across all indications. According to the press release, this marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by an FDA Advisory Committee, and FDA will take this recommendation into consideration when determining whether to approve the application. Pfizer further states that it has already entered into an agreement with Vifor Pharma Inc. for the commercialization of its biosimilar in certain channels.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Goodwin | Attorney Advertising

Written by:

Goodwin
Contact
more
less

Goodwin on:

Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
- hide
- hide