Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Biosimilar Efficacy Trials Can Be Waived under Certain Conditions: MHLW
Japan’s health ministry has clarified that comparative clinical efficacy trials for biosimilars can be omitted if sufficient data demonstrate equivalence or similarity to the reference biologic through pharmacokinetic (PK) or pharmacodynamic (PD) studies. The Ministry of Health, Labor and Welfare…
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