Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
Japan’s drug regulator is urging biosimilar developers to move away from comparative efficacy studies (CES) as a default and adopt a quality-driven approach to determining what studies are actually needed. Rather than conducting CES “by default,” companies should identify what…
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