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Home » Hospira’s Epoetin Biosimilar Delayed Following CRL Over GMP Violations
Hospira’s Epoetin Biosimilar Delayed Following CRL Over GMP Violations
Pfizer and its generic injectables arm, Hospira, received a complete response letter for their proposed biosimilar of epoetin alfa, also known as Epogen and Procrit, following manufacturing issues cited in a February FDA warning.