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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.
Original Article: Pfizer’s biosimilar gets a second knock-back from FDANEXT ARTICLE
Pfizer is a global pharmaceutical company, the largest in world based on annual sales. In 2009, annual sales were worth $45,448m. Pfizer spend £550m on R&D in the UK alone, and have colleagues in 180 countries. Lipitor, one of its produ...
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...