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
- Novartis Overhauls Sales Model to Prioritize Solving Regional Treatment Gaps
November 14, 2025
- Keytruda Again Tops Japan Market in July-September: IQVIA
November 14, 2025
- UK Clears Monthly IV Maintenance Dosing for Leqembi: Eisai/Biogen
November 14, 2025
- Kaken Gets Select-Asia Rights to Numab’s Multi-Specific Antibody
November 14, 2025
- Pluvicto, Imaavy, Hernexeos Now Available in Japan
November 13, 2025
In the complex tapestry of leadership, awareness isn’t just a desirable trait; it’s the bedrock upon which success is built. It’s the lens through which leaders perceive, interpret, and navigate the ever-shifting landscape of their organizations and industries. Without it,…





