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

Plus Five-Product Bonanza For Novartis

 
• By Ian Haydock

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 atrophy treatment Zolgensma (onasemnogene abeparvovec) and Beovu (brolucizumab), the anti-VEGF treatment for wet age-related macular degeneration

More from Japan

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By Lisa Takagi

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

Japan Expands Priority R&D List For Regular Vaccinations

 
• By Lisa Takagi

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

More from Asia

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.