Materials Available for May 25, 2017 ODAC Meeting Regarding Hospira’s Epoetin Alfa Biosimilar Application

Biosimilar News  •  U.S. FDA News

As we previously reported, the FDA announced that the Oncologic Drugs Advisory Committee (ODAC) will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa).   The FDA has now posted meetings materials associated with the May 25th meeting.  The ODAC Briefing Document, which was included in those materials, states that “[i]n considering the totality of the evidence, the data submitted by the Applicant show that ‘Epoetin Hospira’ is highly similar to US-licensed Epogen/Procrit, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ‘Epoetin Hospira’ and US-licensed Epogen/Procrit in terms of the safety, purity, and potency of the product.”  It further states that the “FDA requests discussion at the Oncologic Drugs Advisory Committee to obtain feedback and insights whether the totality of evidence presented support licensure of ‘Epoetin Hospira’ as a biosimilar to US-licensed Epogen/Procrit.”

Further information regarding the May 25th ODAC meeting, including meeting materials, can be found here.

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