FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

WHO to Begin Prequalifying Biosimilars for UN Use

May 12, 2017

The World Health Organization plans to launch a pilot project this year for prequalifying biosimilars, and is inviting manufacturers to submit applications for versions of two cancer treatments on the WHO Essential Medicines List: rituximab and trastuzumab.

If the WHO finds that the biosimilars submitted for prequalification are comparable to originator products in terms of quality, safety and efficacy, the medicines will be listed by WHO and become eligible for procurement by United Nations agencies.

The WHO also plans to advocate for lower prices for all biologic drugs, including supporting countries’ efforts to develop price-setting strategies and incentives for producers to keep manufacturing the needed medicines.

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