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
- Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
- Health Minister Signals Early March Approval for iPSC Products
February 20, 2026
- Takaichi Urges Public-Private Investment Push in Drug Discovery
February 20, 2026
- Two iPSC-Derived Products Now in Line for Conditional Approval
February 20, 2026
- PM Takaichi Keeps Cabinet Intact after Lower House Vote
February 18, 2026
I recently sat down with one of the leading medical directors in Japan to discuss the critical evolution of the medical science liaison (MSL) role.The MSL has transformed from a scientific resource into a strategic partner essential for successful product…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…