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WHO invites bio prequalification

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Executive Summary

An invitation to participate in a pilot procedure for the prequalification of both branded and biosimilar rituximab and trastuzumab has been published by the World Health Organization (WHO). First announced last year (Generics bulletin, 15 September 2017, page 5) – after the WHO announced that it would start prequalifying the two oncology treatments (Generics bulletin, 12 May 2017, page 13) – the scheme, titled ‘pilot procedure for prequalification of biotherapeutic products and similar biotherapeutic products’, has been billed by the WHO as “a step forward to support national and global efforts to increase access to and the affordability of biotherapeutic products and their corresponding similar biotherapeutic products”.

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