REGULATORY
Biosimilar Guidelines Nearing 1st Revision in 10 Years, MHLW Taking Public Comments
The Ministry of Health, Labor and Welfare (MHLW) has begun taking public comments on a proposed revision of its guidelines on the development and review of biosimilars, which went into effect in 2009. It will receive public comments through July…
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In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





