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FDA rejects Pfizer's marketing application for Epogen biosimilar

Published 06/22/2017, 04:31 PM
© Reuters.  FDA rejects Pfizer's marketing application for Epogen biosimilar
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  • Pfizer (NYSE:PFE) receives a Complete Response Letter (CRL) from the FDA regarding its marketing application seeking approval of its biosimilar to Amgen's (NASDAQ:AMGN) Epogen (epoetin alfa). The CRL relates to a warning letter issued in February after an on-site inspection of the company's McPherson, KS facility, a potential manufacturing site for the product.
  • The company says it is working with the agency to address the issues.
  • Source: Bloomberg First Word
  • Now read: Biotech Forum Daily Digest: Biotech Breaks Out! Spotlight On Aclaris Therapeutics


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