REGULATORY
    Kisunla Price Cut Set at 3.93% under Japan’s CEA Scheme
    November 6, 2026
    Japan will trim the NHI price of Eli Lilly Japan’s Alzheimer’s treatment Kisunla (donanemab) by 3.93% under the cost-effectiveness assessment (CEA) scheme, effective February 1, 2027.The Central Social Insurance Medical Council (Chuikyo) approved the revised…

    LATEST

    Regeneron Files MM Drug Linvoseltamab in Japan
    November 6, 2026
    Regeneron Japan said on November 6 that it has filed for the Japanese approval of its bispecific antibody linvoseltamab for adults with relapsed or refractory multiple myeloma who have received at least three prior therapies…
    Japan Nudged to Probe Wide Gaps in Biosimilar Uptake
    November 6, 2026
    Japan should investigate why biosimilar uptake varies so widely across products, a health ministry panel member urged on November 5, as new government data showed that only two of 20 biologic ingredients with biosimilar alternatives…
    Fuji Pharma Recalls Eylea Biosimilar Lots over Faulty Finger Grips
    November 6, 2026
    Fuji Pharma and Nitto Medic have initiated a voluntary Class II recall of certain lots of Japan’s first Eylea (aflibercept) biosimilar due to a defect in a finger grip attached to the syringe to assist…

    COLUMN

    New York Note - 2: The Tariff Roller Coaster
    By Shunsuke Tani

    Tariffs have been a defining feature of US trade policy under President Donald Trump’s second administration. Since Trump unveiled his “reciprocal” tariff policy in April 2025, the landscape has shifted repeatedly.In February 2026, the US Supreme Court invalidated tariffs imposed…

    Off-Year Drug Price Revisions

    MOF Presses for Full FY2027 Drug Price Revision Without Price Gap Thresholds
    By Kohei Hori

    As Japan’s budget season draws near, the Ministry of Finance (MOF) has renewed its push for a full-scale “off-year” drug…

    COMMENTARY

    Deeper CEA Price Cuts Demand More Than a “Certain Degree of Validity”
    By Ken Yoshino

    Japan is pressing ahead with broader drug price cuts under its cost-effectiveness assessment (CEA) system, despite lingering questions over the…

    Cost Effectiveness Assessment (2025-)

    Chuikyo Reps Back More Pharma Access to CEA Deliberations, Urge Neutrality
    By Kohei Hori

    Members of a key reimbursement policy panel on October 28 raised no objections to expanding drug makers’ access to deliberations…

    Drug Approval & Reimbursement in 2026

    Imulrio Finally Set for NHI Listing after 296-Day Wait; Zero Rule Strikes Again
    By Takashi Ebisawa

    Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…

    FY2026 Drug Pricing Reform

    Romiplate to See Steepest Cut in April Market Expansion Re-Pricing

    Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…

    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,…

    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…

    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…

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