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FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

10:41 EDT 23 Jun 2017 | Speciality Pharma Journal

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in a Warning Letter issued on …

Original Article: FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

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