FDA Clears Hospira's Biosimliar Of Amgen's Epogen

Law360 (May 15, 2018, 7:05 PM EDT) -- The U.S. Food and Drug Administration on Tuesday approved Hospira’s Inc.’s anemia medication Retacrit, a biosimilar of Amgen Inc.’s blockbuster biologic Epogen, bringing the total number of biosimilars approved by the agency to 10.

The FDA had initially refused to approve Retacrit in June 2017, citing issues from a manufacturing inspection that led to Hospira's parent company, Pfizer Inc., receiving a warning letter from the agency. But now the FDA has cleared Retacrit to treat anemia caused by chronic kidney disease, the HIV medication Zidovudine, various types...
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