Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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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COMMENTARY
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