Japan's MHLW consults on biosimilars
The Japanese Ministry of Health, Labor and Welfare has this month announced a consultation, calling for public comment on its first drafted guidelines regarding the quality, safety and efficacy of biosimilar pharmaceutical products, or follow-on biologics.
In the guidelines, biosimilars - which are proposed non-branded versions of biotechnology drugs on which intellectual property rights have expired - are defined as follow-on products such as genetic recombinant proteins including simple proteins, polypeptides and their derivatives, notes the Marketletter's local reporter.
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