Pfizer’s Epogen/Procrit Biosimilar gets FDA Advisory committee green light

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.

For more information, visit http://www.pfizer.com/news/press-release/press-releases-archive