Pfizer announced the FDA Oncologic Drugs Advisory Committee recommended approval of the Company’s proposed Epogen (Amgen) / Procrit (Johnson and Johnson) biosimilar across all indications. This is the first epoetin alfa biosimilar that has been recommended for approval by a U.S. FDA Advisory Committee. The product indications include treatment of anemia due to Chronic Kidney Disease (CKD), Zidovudine in HIV-infected patients, and the effects of some chemotherapy treatments. The FDA will take the Committee’s recommendation into consideration before taking action on the Biologics License Application (BLA) for the product.
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