Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Japan’s 2nd Enbrel Biosimilar, Pfizer’s Herceptin Follow-On Get Listing
Japan’s second Enbrel (etanercept) biosimilar by YL Biologics will join the NHI price list on May 29 along with a batch of new products that also include Pfizer’s Herceptin (trastuzumab) follow-on, the government’s official gazette revealed on May 28. Enbrel,…
To read the full story
Related Article
- Kyowa to Skip May Listing for Enbrel Biosimilar, Codeveloper YL Biologics to Move Ahead
April 11, 2019
- Japan Clears Second Enbrel Biosimilars
March 27, 2019
- Pfizer Skips Listing of Herceptin Biosimilar, Daiichi Sankyo Goes Ahead
November 27, 2018
REGULATORY
- Japan Drug Prices to Fall 4% in FY2026 Revision: Official Gazette
March 5, 2026
- Romiplate to See Steepest Cut in April Market Expansion Re-Pricing
March 5, 2026
- MHLW Clarifies Use of Real-World Data in Drug Applications
March 5, 2026
- MHLW Expands Eligibility for “Specific-Use Drug” Designation
March 5, 2026
- MHLW to Launch Priority Review Pathway for Overseas Alternatives amid Drug Shortages
March 5, 2026
Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…
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…
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…