HOME > REGULATORY

    REGULATORY

    Epkinly, Lunsumio to Face Price Cut of 2.7% under CEA Scheme

    May 15, 2025
    Genmab’s Epkinly (epcoritamab), a bispecific antibody targeting CD20/CD3, will see its prices trimmed by 2.7% in August under the cost-effectiveness assessment (CEA) scheme. Chugai Pharmaceutical’s Lunsumio (mosunetuzumab) in the same class will also take a hit in a spillover. The…

    To read the full story

    Related Article

    REGULATORY

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo OKs New CEA Handling, with Third-Party Verification Ahead

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

    COMMENTARY

    ICH Weighs Need for Biosimilar Efficacy Trials as Regulators Move Away from Routine Use
    By Takashi Ebisawa

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

    COLUMN

    The Strategic MSL: Beyond Data Delivery, It’s About Impact
    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…

    Drug Approval & Reimbursement in 2025

    Chuikyo OKs Listing of Novartis’ Pluvicto, Peak Sales Outlook at 42.1 Billion Yen

    Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…

    Chuikyo Debate on Off-Year Drug Price Revisions

    MHLW Unveils New List Prices for FY2025 Revision; Stelara, Januvia Hit by PMP Return
    By Ken Yoshino

    The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…

    Discussions on Next PMD Act Amendment

    Japan Cabinet Approves Bill to Amend PMD Act

    The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…

    Drug Approval & Reimbursement in 2024

    Japan Approves Zepbound, Qalsody, and Lots More Drugs

    Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…

    Chuikyo on FY2024 Reimbursement Reform

    Chuikyo OKs Outline of FY2024 Drug Pricing Reform; No Unprofitability Re-Pricing for 7%-Plus Price Gap

    Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…