Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
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
- 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
- DMD Gene Therapy Elevidys Hits Japan Market at Record Price
February 20, 2026
- Bayer Eyes Kerendia as Standard Therapy for CKM Syndrome
February 20, 2026
- Enhertu Accepted for EU Review in Post-Neoadjuvant HER2 Breast Cancer
February 20, 2026
- SymBio Receives Grant for Antiviral Brincidofovir
February 20, 2026
- Over 40% of Breast Surgeons Largely Unaware of Clinical Trials: Survey
February 20, 2026
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…
Following Hisamitsu Pharmaceutical’s decision to go private through a roughly 400 billion yen management buyout (MBO), industry observers are weighing…
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…