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

    Forxiga Slapped with 36% Price Cut on PMP Return in FY2026 Revision
    March 6, 2026
    Quick Look:The PMP return will hit 28 APIs in the FY2026 drug price revision, generating total savings of 91.8 billion yen.Forxiga will suffer a hefty 36% cut, with Eylea, Zytiga, Abraxane, Orencia, and Vectibix also…
    Positive Price Revisions Seen at Several Firms in FY2026 Reform: Poll
    March 6, 2026
    Several pharmaceutical companies will see net price increases under Japan’s FY2026 drug price revision, according to a Jiho survey of drug makers on the impact of the latest round of NHI price adjustments.Among the 42…
    Japan Panel Clears Joenja, Dojolvi, Bayer MRI Contrast Agent
    March 6, 2026
    Quick Look:An MHLW panel recommended approval for three NMEs on March 5: OrphanPacific’s leniolisib, Ultragenyx’s triheptanoin, and Bayer’s gadoquatrane.The session also supported label expansions for Lusefi and Effexor, while the ministry reported plans to approve…

    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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