Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Celltrion Is Developer of Japan’s Third Stelara Biosimilar in the Wings
Celltrion Healthcare is expected to be third to market in the Stelara (ustekinumab) biosimilar space in Japan, with its version of the psoriasis drug now given the Japanese non-proprietary name, or JAN, Jiho has learned. On January 28, the Ministry…
To read the full story
Related Article
- Celltrion Files Biosimilar without Japanese Clinical Data, More Firms Might Follow
October 24, 2025
- J&J’s Lazcluze, Genmab’s Tivdak and More Drugs in Line for Japan Approval
February 28, 2025
- J&J’s Lazcluze, Genmab’s Tivdak, and More Up for MHLW Panel Review on Feb. 27
February 14, 2025
- Celltrion Set for 6 Biosimilar Filings in 2 Years, Sees Japanese Data Waiver as a Boon
February 6, 2025
- Celltrion Japan Unveils New List of 5 Biosimilars in Development; Actemra and Pralia and More
May 1, 2024
REGULATORY
- Cabinet-Backed Health Insurance Bill Targets Childbirth Costs, Copay Reform
March 16, 2026
- Japan Cabinet Approves Health Insurance Bill with OTC-Like Drug Charges
March 16, 2026
- LDP Urges Action on Drug Supply Risks Linked to Reliance on Specific Countries
March 16, 2026
- 874 Defects or Health Damages Reported for Regenerative Medical Products in 1H FY2025
March 13, 2026
- Chuikyo OKs Listing of J&J’s Rybrofaz, Peak Sales Seen at 43.8 Billion Yen
March 12, 2026
The launch of Elevidys has opened the door to gene therapy for DMD, but research into new treatments is already…
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…