www.fdanews.com/articles/183414-who-launches-pilot-program-for-prequalifying-biosimilars
WHO Launches Pilot Program for Prequalifying Biosimilars
September 8, 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.