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Japan Nods Include Global Firsts For Duvroq, Vafseo And First Local Biosimilar Humira

Plus Five-Product Bonanza For Novartis

Executive Summary

Japan’s regulators have approved a large batch of new products, including a novel antibody from Chugai, two world-first nods for the country’s second HIF-PH inhibitors and an asthma therapy, and the first Humira biosimilar in Japan – as well as five drugs from Novartis.

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While it was not as affected as some other countries, Japan still had the pandemic to deal with and regulators responded while managing to keep up regular product review work, including several world-first approvals. Coronavirus vaccine roll-outs and the first general annual reimbursement price cut are on the cards for this year. 

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