Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…
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
- Regeneron Files MM Drug Linvoseltamab in Japan
November 6, 2026
- Fuji Pharma Recalls Eylea Biosimilar Lots over Faulty Finger Grips
November 6, 2026
- Medipal Sets Dec. 15 Shareholder Meeting, Opposes Chairman’s Ouster
November 6, 2026
- Nitrosamine Impurities Reported for Generic Telmisartan; No Recalls Planned
November 6, 2026
- Bracco Japan to Acquire Iopamiron from Bayer in July 2027
November 6, 2026
As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…
Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…
Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
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…