Executive Summary of WHO Implementation Workshop: Revised WHO Guidelines on Evaluation of Biosimilars

Overview

The WHO implementation workshop on the revised WHO guidelines on evaluation of biosimilars was held from 26 to 28 November 2025 in Tunis, Tunisia as a hybrid meeting. The workshop was attended by 72 participants (51 in-person, 21 virtually connected) including representatives from national regulatory authorities (NRAs) in the African and Eastern Mediterranean regions, regulatory experts from 5 WHO regions, the Tunisian NRA, manufacturers’ associations, Tunisian manufacturers and research institute, as well as WHO staff.