Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
1st G-Lasta Biosimilar Gets Japan Listing, Stelara Follow-On Not on Roster
The first biosimilar versions of the G-CSF agent G-Lasta (pegfilgrastim) in Japan will join the NHI price list on November 22, along with a fourth follow-on of the anti-TNFα antibody Humira (adalimumab), according to the government’s official gazette issued on…
To read the full story
Related Article
- High Demand Triggers Shipment Curb for G-Lasta Biosimilars
March 14, 2024
- Mochida Intends to Carve Out Market Share with 1st G-Lasta Biosimilar
December 13, 2023
- Phesgo, Epkinly, Leqvio Hit Japan Market, Wegovy Launch Set for Feb. 22
November 24, 2023
- Japan Approves Multiple Firsts, Leqembi, Arexvy, Leqvio, and More
September 26, 2023
- Perjeta/Herceptin SC Combo, 1st Stelara, G-Lasta Biosimilars in Line for Japan Approval
August 1, 2023
- Japan’s 1st Stelara, G-Lasta Biosimilars Nearing Finish Line
July 18, 2023
REGULATORY
- MHLW Lifts Part of Approval Conditions for Takeda’s Vyvanse
June 9, 2026
- Drug Makers Seek Govt Support for Immunoglobulin Plant Investments: LDP Hearing
June 9, 2026
- Japan Govt Likely to Slim Down Honebuto, but Details Remain Elusive
June 8, 2026
- Leqembi, Kisunla Labels Revised to Strengthen ARIA Monitoring
June 8, 2026
- Japan Tightens Oversight of Mounjaro Resales: Health Minister
June 8, 2026
Japan is finally launching technical discussions on its cost-effectiveness assessment (CEA) system. A health ministry-funded research group is set to…
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…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…