Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
6 Drugs Face Generic Entries, 2 Firms to Roll Out Symbicort Copies: December Listing
Six drugs will newly see the entry of generic competitors in Japan upon their listing on December 13 including Symbicort (budesonide + formoterol), with two companies poised to pit their products against AstraZeneca’s major COPD treatment, which raked in 47…
To read the full story
Related Article
- 15% Share Eyed for Jointly Developed Symbicort Generics, Toa Set to Push Uptake with Support App
December 25, 2019
- Japan OKs Zetia Generic, Possibly AG, towards December Listing; No Entry for Lyrica This Time
August 16, 2019
- Toa Confident in Ensuring Stable Supply of Symbicort Generic with Expertise in Dry Powder Inhaler Manufacturing
March 8, 2019
- Nihon Generic Taking Pass on June Listing of Symbicort Copies; 2 Partners Mum
February 27, 2019
- Toa, Nipro, Nihon Generic Codeveloped Symbicort Copies, Launch Timing Unclear
February 18, 2019
- Japan Approves Symbicort Generics, Asthma Drug Stalwart Could Face Competition in June
February 15, 2019
REGULATORY
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 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…