Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
BUSINESS
Celltrion Files Biosimilar without Japanese Clinical Data, More Firms Might Follow
South Korea's Celltrion appears to have become the first company to seek Japanese approval for a biosimilar without local clinical trial data, submitting its Eylea (aflibercept) follow-on after a regulatory change early this year. The new policy, introduced by the…
To read the full story
Related Article
- Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
March 6, 2026
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Japan Panel to Review Joenja, Dojolvi for Approval at March 5 Session
February 27, 2026
- Celltrion Set for 6 Biosimilar Filings in 2 Years, Sees Japanese Data Waiver as a Boon
February 6, 2025
- Celltrion Is Developer of Japan’s Third Stelara Biosimilar in the Wings
January 29, 2025
- Celltrion Japan Unveils New List of 5 Biosimilars in Development; Actemra and Pralia and More
May 1, 2024
- English Versions of MHLW Biosimilar Trial Guidance, Q&As Now Available
March 13, 2024
- MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
January 26, 2024
- Celltrion Aims to Market 11 Biosimilars in Japan, Infliximab “Biobetter” in the List
October 3, 2022
BUSINESS
- Merck Biopharma Starts Japan PIII Trial of LH/FSH Combo
July 17, 2026
- Eisai’s Dayvigo Accepted for EMA Review
July 17, 2026
- AbbVie Files Maviret for Acute Hepatitis C
July 17, 2026
- FRONTEO, Santen Advance AI Drug Discovery Project to Second Phase
July 17, 2026
- Ferring’s Adstiladrin, Boehringer’s Jascayd Hit Market; Haizexin Due July 28
July 16, 2026
Japan’s pharmaceutical industry could be on the verge of gaining a stronger voice in the Central Social Insurance Medical Council…
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 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…