World Health Organization announces biosimilar prequalification project

Biosimilar News  •  Regulatory Guidances

The World Health Organization (WHO) announced today plans to launch a pilot project for prequalifying biosimilar medicines later this year. The project will initially focus on biosimilar versions of two cancer treatments, rituximab and trastuzumab, with possible expansion into prequalifying insulin. WHO will begin accepting applications this September and will prequalify biosimilars if they are found to be comparable to originator products in terms of quality, safety and efficacy. Once prequalified through this project, the medicines will be listed by WHO and be eligible for procurement by United Nations agencies.  WHO is seeking to expand access to these treatments especially in low- and middle-income countries and support countries in regulating these medicines.

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