Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan OKs Biosimilars of Eylea, Actemra, Simponi, Ranmark in Likely First Debut
The Ministry of Health, Labor and Welfare (MHLW) on September 19 approved the biosimilars of four major drugs, including follow-ons to Eylea (aflibercept) and Actemra (tocilizumab). Companies behind the filings are now aiming to secure NHI listing in November, which…
To read the full story
Related Article
- Japan to List 1st Biosimilars for Xolair, Ranmark, Simponi on May 20
May 19, 2026
- Celltrion’s Eylea Biosimilar Nears Approval, but Listing Outlook Clouded
February 27, 2026
- Celltrion Sets April 28 Launch Date for Japan’s 1st Actemra Biosimilar
February 17, 2026
- Celltrion to Launch Japan’s First Actemra Biosimilar in Late April
February 12, 2026
- Fuji Says Eylea Biosimilar Patent Risk Cleared under Global Settlement
February 2, 2026
- Top Court Rejects Samsung Challenge to Patent-Linkage Disclosures in Eylea Biosimilar Case
January 27, 2026
- Bayer/Santen to Launch Eylea Bio-AG on February 2
January 9, 2026
- Japan’s 1st Eylea Biosimilar to Reach Market on January 7
December 19, 2025
- Santen to Market Bayer’s Eylea Bio-AG; Launch Date Still Undisclosed
December 8, 2025
- Eylea Bio-AG to Carry DME Indication Missing from Fuji’s Biosimilar Label
December 5, 2025
- Bayer’s Eylea Bio-AG Finally Reaches NHI Listing amid Reform Talks
December 4, 2025
- Bayer, Regeneron Move to Block Fuji’s Newly Listed Eylea Biosimilar in Japan
November 13, 2025
- Japan’s 1st Biosimilars for Eylea, Actemra Get NHI Listing in November
November 11, 2025
- Fuji, J&J Reach Agreement on Simponi Biosimilar for 2026 Debut
November 5, 2025
- Fuji Inks Deal with Daiichi on Ranmark Biosimilar, Now Plans 2026 Launch
November 4, 2025
- Inside Eylea - 1: Patent Issues Behind Differences in Biosimilar Indications for AMD and DME
October 6, 2025
- Japan Approves Pluvicto, Izervay, and Lots More; Subcutaneous Rybrevant Not on Roster
September 22, 2025
- Fuji, Nitto Strike Sales Deal for Eylea Biosimilar, Eye November Listing
September 2, 2025
- Japan Panel Clears Izervay, Nexletol for Approval; Eylea Biosimilars Edge Ahead Too
September 1, 2025
- Japan Nears Approval for 1st Biosimilars of Actemra, Simponi, and Ranmark
August 12, 2025
REGULATORY
- AMED-Backed R&D Yielded 31 Regulatory Approvals in FY2025
July 17, 2026
- MHLW to Reconvene HSC Regulation Panel for First Time in a Year
July 17, 2026
- MHLW Allows Exceptional Concerta Pharmacy Transfers
July 17, 2026
- Japan to Consider Support for Domestic Immunoglobulin Production: Minister
July 16, 2026
- Govt Set to Amend Honebuto Draft over Inflation, MFN Language
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…