Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Vimpat Draws 10 Generic Entrants in December Listing; Forxiga Has Two, but Nipro AG Absent
Six APIs will see first-time generic entries in the next round of biannual generic listing on December 5, including 10 versions of UCB Japan’s antiepileptic Vimpat (lacosamide) and two of AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin), according to an official gazette.…
To read the full story
Related Article
- Forxiga Generics Launch in Japan at 33.6% of Originator Price: Sawai, T’s Pharma
December 5, 2025
- Vimpat Copies Hit Shelves at 35% of Originator Price as 10 Firms Flock to Market
December 5, 2025
- Vimpat Generics Win Added Use, Clearing Path for Full-Label Launch
December 4, 2025
- Sawai and T’s Pharma Won Forxiga Generics by Skirting Patent, Will the Strategy Hold?
September 11, 2025
- AGs Identified for 4 Brands in Latest Generic Approvals, Including Bonviva and Epadel
August 19, 2025
- Espha to Launch Authorized Generic of Zytiga in December
August 19, 2025
- Nipro Secures AG for Forxiga, Sawai and Teva Takeda Go Without Hydrate
August 18, 2025
- Japan Approves First SGLT2 Generics, 12 Firms Pile into Vimpat Ahead of December Listing
August 18, 2025
REGULATORY
- Takaichi Signals Continued Off-Year Revisions despite Abolition Calls
February 26, 2026
- LDP Panel Delays Approval of Health Insurance Bill amid Concerns over OTC-Like Drug Charges
February 26, 2026
- MHLW Orders Colchicine Label Revision, Warns against Doses above 1.5 mg per Day
February 26, 2026
- Symbicort Switch to OTC Status Gains No Support at MHLW Panel
February 25, 2026
- Japan Govt Council Finalizes Recommendations for National MCM Strategy
February 25, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
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…