Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Daiichi Sankyo's Herceptin Biosimilar Now in Line for September Approval as It Clears MHLW Panel
Daiichi Sankyo’s Herceptin (trastuzumab) biosimilar cleared a key health ministry advisory panel on August 3, opening the way for approval both in gastric and breast cancer indications in September and NHI reimbursement listing in November, if all goes well. The…
To read the full story
Related Article
- Pfizer’s Lorlatinib Gets 1st Conditional OK; MHLW Approves Astellas AML Drug and More
September 25, 2018
- Opdivo Defended Crown with Ono’s Asia Sales Added, but Keytruda Triumph Would Come Soon
August 6, 2018
- Daiichi Sankyo’s Herceptin Biosimilar Might Hit Market as Early as November, Breast Cancer Use Also Eyed
July 23, 2018
REGULATORY
- LDP Panel Finalizes Honebuto Proposal on Preventive Care, Adds Obesity Focus
June 5, 2026
- Ex-GSK Japan Head Calls for End to "Obsolete" 14-Day Prescription Limit
June 5, 2026
- Trazenta Generic Outlook Remains Clouded as Court Upholds Treatment-Method Patents
June 4, 2026
- LDP Generic Caucus Wants Swift Disclosure of Company Indicator Ratings
June 4, 2026
- LDP Social Security Panel Pushes Greater Reward for Innovation: Honebuto Proposal
June 3, 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…