REGULATORY
    Avastin Price to Be Axed by 45% as G1 Rule Hits Originator Biologics
    By Shinya Sato March 6, 2026
    Quick Look:Japan will impose steep price reductions on several off-patent biologics in April as the G1 rule is extended to originators facing biosimilar competition.Avastin will see the largest cut at 45%, while others braced for…

    LATEST

    Nitrosamine Detected in Nichi-Iko’s Tryptanol, No Need to Halt Prescriptions
    March 9, 2026
    Nichi-Iko Pharmaceutical said on March 6 that a nitrosamine impurity, N-nitrosonortriptyline, has been detected in its antidepressant Tryptanol (amitriptyline) at levels exceeding the acceptable intake limit set by the European Medicines Agency (EMA).The company disclosed…
    Pfizer, ASKA to Co-Promote RSV Vaccine Abrysvo in Japan
    March 9, 2026
    Pfizer and ASKA Pharmaceutical said on March 6 that they will begin co-promoting the maternal respiratory syncytial virus (RSV) vaccine Abrysvo in Japan starting April 1 — in conjunction with the shot’s inclusion in the country’s routine immunization program.The companies…
    Japan Approves MSD’s HIV Combo Idvynso
    March 9, 2026
    Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 6 granted regulatory approval to MSD’s once-daily HIV combination therapy Idvynso (islatravir/doravirine).The approval comes days after a March 2 recommendation by the Pharmaceutical Affairs Council’s…

    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

    G1 Rule to Hit Originator Biologics for First Time, Impact Seen for Up to 13 Brands
    By Shinya Sato

    Japan’s FY2026 drug pricing reform will, for the first time, apply the “G1” price cut rule for long-listed original biologics…

    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…

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