Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
BUSINESS
Celltrion Set for 6 Biosimilar Filings in 2 Years, Sees Japanese Data Waiver as a Boon
Celltrion is poised for a string of biosimilar submissions in Japan. Last year, the company filed two follow-on biologics, including one for Actemra (tocilizumab), and it expects four more before the end of 2025, among them being its version of…
To read the full story
Related Article
- Japan’s 1st Xolair Biosimilar Likely from Celltrion as JAN Is Assigned
January 23, 2026
- Celltrion Files Biosimilar without Japanese Clinical Data, More Firms Might Follow
October 24, 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
- Japan’s Big 4 Drug Wholesalers See Profit Pressure Intensify in FY2025
May 19, 2026
- Asahi Kasei Starts Japan PIII of Extended Teribone Dosing
May 19, 2026
- Allergan Files Botox Vista for Forehead Wrinkles
May 19, 2026
- Stella Begins Japan PIII of BNCT for Recurrent Glioblastoma
May 19, 2026
- Enhertu Earns 2 US Approvals in HER2-Positive Early Breast Cancer
May 19, 2026
Japan’s pharmaceutical industry is undergoing a structural shift in its workforce, with the role of sales reps shrinking while production…
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…
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…