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
- Nipro to List Forxiga AG in June Ahead of Pricing Rule Shift
April 30, 2026
- 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
- Japan Begins Review of Domestic CGT Seeds with Limited Market Potential
June 30, 2026
- Govt Panel Urges 2027 Bill to Expand Secondary Use of Health Data
June 30, 2026
- Japan Panel OKs Carvykti’s Earlier Use in Multiple Myeloma
June 30, 2026
- Govt to Explore Greater Rewards for Innovative Drugs in Honebuto
June 29, 2026
- MHLW Starts Technical Review of OTC-Like Drug Charge Exemptions
June 29, 2026
Let’s face it: in today’s world, changing jobs is a normal part of a successful career. But if it’s so normal, why does it feel so hard? For many people, the idea of leaving their current role brings a heavy…
Japan’s leading pharmaceutical wholesalers are bracing for a second consecutive year of profit declines, underscoring the growing challenge of generating…
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…