Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
Chuikyo OKs 70% Pricing for Nesp Biosame; New Rules Up for FY2020 Reform Debate
A key drug pricing panel on March 27 agreed to price the so-called “biosame” version of the Nesp (darbepoetin alfa) renal anemia drug at 70% of the originator - just as biosimilars - in a stopgap measure as the product’s…
To read the full story
Related Article
- Nesp Biosame to Hit Japan Shelves on August 5
July 29, 2019
- After 70% Pricing OK’ed for Biosame, Nesp Biosimilar Developers Stay Pat on November Listing Plans
March 28, 2019
- Nesp Biosame Likely to Be Priced at 70% of Originator as Stopgap Measure
March 26, 2019
- Balancing Act: All Eyes on Nesp Biosame Pricing before June 2019 Listing, Biosimilars to Follow in November
November 5, 2018
- Nesp Biosame to Hit Japan Market in July-September 2019
October 31, 2018
REGULATORY
- Japan Panel Backs Daiichi’s MMR Vaccine, Haihe’s PI3Kα Inhibitor, MSD’s HIV Med
March 3, 2026
- MHLW Revises Guidance on Pediatric Development Plans under Amended PMD Act
March 3, 2026
- MHLW Details New Operational Rules for Conditional Approvals from May
March 3, 2026
- MHLW Seeks Sponsors to Develop 8 “Drug-Loss” Products
March 2, 2026
- WG Members Urge Domestic Biologic Production as National Growth Strategy
March 2, 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…