FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

WHO Launches Pilot Program for Prequalifying Biosimilars

Sept. 11, 2017

The World Health Organization hopes to take a step toward reducing the prices of biologic cancer medicines in less affluent nations through a pilot program to prequalify biosimilars.

The agency is asking manufacturers to apply initially for prequalification of biosimilars for two products on its list of essential medicines: rituximab, used to treat non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, and trastuzumab, a breast-cancer medication.

Favorable reviews by WHO would make the biosimilars eligible for purchase by UN agencies. The governments of many low- and middle-income countries also rely on WHO prequalifications in making drug purchases.

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