Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW Official Expounds on “Authorized Biosimilar” Pricing, 50% Generic Rule Applies for “Biosame” Products
If a follow-on biologic is manufactured under the exact same conditions as those for its originator, this “biosame” product will be handled as a “generic” under the current pricing rules in Japan, receiving an NHI price 50% of the originator’s,…
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