FDAnews Drug Daily Bulletin

Hospira’s Epoetin Biosimilar Delayed Following CRL Over GMP Violations

June 27, 2017

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.

The warning letter was issued following a routine FDA inspection of a McPherson, Kan., Hospira facility in spring 2016, listing significant GMP violations for finished pharmaceuticals, though unrelated to the production of epoetin.

In its warning letter, the FDA said the facility did not thoroughly investigate unexplained discrepancies in batches or components; failed to establish valid in-process specifications, or follow written contamination prevention procedures; nor establish appropriate laboratory controls.

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