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WHO Consults On Kick-Starting Pilot On Prequalification Of Biosimilars

Executive Summary

The World Health Organization is making inroads into its plan to prequalify biosimilars, starting with a pilot project involving two anti-cancer medicines. It has developed two assessment pathways to prequalify biosimilars, depending on whether not these products are already approved by a stringent regulatory authority. During the pilot phase, the fees associated with prequalification will be waived.

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