COMMENTARY

Lively Debate on Generic Industry Revamp Underway, All Eyes on Consortium Model

By Takashi Ebisawa July 12, 2024
Earlier this month, Health Minister Keizo Takemi called on the top executives of 13 major generic makers to restructure the industry with a product consolidation target of “around five companies per API.” While a variety of restructuring options are conceivable,…

To read the full story

COMMENTARY

Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…

By Takashi Ebisawa

International regulators are increasingly moving away from comparative efficacy studies (CES) in biosimilar development — long considered a default requirement…

By Philip Carrigan

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,…

By Ken Yoshino

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…