April 23, 2018 / 11:57 AM / in 7 months

FDA declines to approve Pfizer's biosimilar to Roche's cancer drug

April 23 (Reuters) - Pfizer Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve the company’s biosimilar to Roche’s breast cancer drug, Herceptin, and sought additional technical information. The company said the information requested by the FDA does not relate to safety or clinical data submitted in the application. (Reporting by Akankshita Mukhopadhyay in Bengaluru; Editing by Anil D’Silva)

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