Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
COMMENTARY
ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement in the approval process — and the shift could eventually reach Japan as well, as global harmonization work gets underway.…
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