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

Plus Five-Product Bonanza For Novartis

30 Jun 2020

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.

Hand rubbers stamps approval on documentation — Multiple Major New Approvals In Japan • Source: Shutterstock

Japan’s ministry of health, labor and welfare (MHLW) has issued formal final approvals to a sizable group of new drugs which includes a number of significant products - the country’s first biosimilar version of Humira, second novel HIF-PH inhibitor for renal anemia and a cluster of five products from Novartis, which the Swiss group described as an “unprecedented milestone.”

Novartis AG has now received seven new product marketing authorizations already in Japan this year, notably including spinal muscular...