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.
Blog Big Molecule Watch May 25, 2017