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Pfizer’s biosimilar gets a second knock-back from FDA

04:46 EDT 23 Jun 2017 | Pharmafile

Pfizer has been dealt a stinging blow by the FDA, after it received a second complete response letter from the Angecy regarding its biosimilar for Amgen’s Epogen. All of the signs seemed to point towards a straight-forward approval, after an advisory committee voted overwhelmingly in favour of the biosimilar yet it stumbled on manufacturing issues.

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