Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Biosimilar Efficacy Trials Can Be Waived under Certain Conditions: MHLW
Japan’s health ministry has clarified that comparative clinical efficacy trials for biosimilars can be omitted if sufficient data demonstrate biosimilarity to the reference biologic through pharmacokinetic (PK) or pharmacodynamic (PD) studies. The Ministry of Health, Labor and Welfare (MHLW) clarified…
To read the full story
Related Article
- PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
August 18, 2026
- CES Waivers Could Slow Biosimilar Uptake without Better Communication: Industry
July 23, 2026
- ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
March 9, 2026
- English Versions of MHLW Biosimilar Trial Guidance, Q&As Now Available
March 13, 2024
- MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
January 26, 2024
- Biosimilar Guidelines Nearing 1st Revision in 10 Years, MHLW Taking Public Comments
July 2, 2019
REGULATORY
- Chuikyo Backs Broader CEA Price Cuts This Year, Snubs Pharma Plea
October 1, 2026
- Repatha Optimal Use Guidelines to Be Simplified
October 1, 2026
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
- MHLW Panel Backs Easing Protopic Contraindication for Young Children
September 30, 2026
- PMDA Flags New Safety Risks with 3 Drugs
September 30, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
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…