FDA rejects Pfizer’s epoetin alfa biosimilar

Biosimilares/Novedades | Posted 14/07/2017 post-comment0 Post your comment

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application for approval of its epoetin alfa biosimilar.


The news comes less than a month after FDA advisers voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa) [1].

Pfizer received a Complete Response Letter (CRL) regarding the company’s Biologics License Application (BLA) for its epoetin alfa biosimilar. The CRL was issued following manufacturing issues cited in a February FDA warning letter.

The warning letter was issued following a routine FDA inspection of a Hospira facility in McPherson, Kansas, USA in 2016, which listed significant good manufacturing practice (GMP) violations for finished pharmaceuticals. Although this facility was listed as the potential manufacturing site in the application for Pfizer’s epoetin alfa biosimilar, the company says that ‘the issues noted in the warning letter do not relate specifically to the manufacture of epoetin alfa’.

This is not the only rejection of a biosimilar application by FDA in the last year. The agency rejected Sandoz’s biosimilar pegfilgrastim application in July 2016 [2] and in June 2017 it rejected another pegfilgrastim biosimilar from Coherus [3].

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Sandoz withdraws biosimilar pegfilgrastim application

Biosimilars of epoetin alfa

1. GaBI Online - Generics and Biosimilars Initiative. FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-advisors-recommend-approval-of-Pfizer-s-epoetin-alfa-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. FDA rejects Sandoz’s biosimilar pegfilgrastim application [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-rejects-Sandoz-s-biosimilar-pegfilgrastim-application
3. GaBI Online - Generics and Biosimilars Initiative. FDA rejects pegfilgratim biosimilar from Coherus [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Jul 7]. Available from: insert once uploaded = www.gabionline.net/Biosimilars/News/FDA-rejects-pegfilgrastim-biosimilar-from-Coherus

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Source: Pfizer

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