Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
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
- Japan to Designate International Clinical Trial Hubs in FY2027
August 28, 2026
- MHLW Tax Reform Requests Cover Support for MCM Preparedness
August 28, 2026
- Patient Group Flags Risks of Inconsistent Decisions on OTC-Like Drug Charges
August 28, 2026
- MHLW Pharma Bureau Eyes 12 Billion Yen to Boost Plasma Product Production
August 28, 2026
- Novo, Lilly Want Reimbursement Support for Obesity Care: LDP Hearing
August 28, 2026
We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
More than a year after Dupixent (dupilumab) became the first antibody therapy approved for COPD in Japan, drug makers are…
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…