BUSINESS
    Will Unlisted AGs Rush for June Listing or Be Left on Ice?
    By Tatsuya Otsuka January 23, 2026
    With new pricing rules set to take effect in October that would put newly listed authorized generics (AGs) and biologic AGs on par with their originator products, the generic industry is increasingly viewing the upcoming…

    LATEST

    Japan’s 1st Xolair Biosimilar Likely from Celltrion as JAN Is Assigned
    January 23, 2026
    Japan’s first biosimilar version of the asthma and allergy treatment Xolair (omalizumab) might be nearing regulatory approval, with the health ministry on January 22 announcing that a Japanese non-proprietary name, or JAN, has been assigned…
    DPP Vows to Scrap Off-Year Drug Price Revisions in Election Platform
    January 23, 2026
    Japan’s Democratic Party for the People (DPP) on January 22 released its policy platform for the upcoming Lower House election, explicitly pledging to abolish “off-year” drug price revisions as part of its overarching pharmaceutical policy stance.The platform — which the…
    Japan Starts Review on Scope of Drugs Eligible for Immunization Use, with Beyfortus in Focus
    January 23, 2026
    Japan has kicked off discussions on the range of pharmaceutical products that can be used for immunization under the Immunization Act — a move that could pave the way for routine inoculation status for Sanofi’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

    Wave of “World Firsts” Looms as 47 New Drug Candidates Line Up for 2026
    By Shinya Sato

    As many as 47 new drug candidates are expected to win approval or secure NHI price listing in Japan in…

    COLUMN

    AI: Your New HR BFF (Not Your Replacement!)
    By Philip Carrigan

    Let’s ditch the stuffy jargon and talk about AI in HR like real humans.One of the biggest myths floating around is that AI is coming to steal our jobs. Newsflash: that’s not happening. Sure, AI can handle the boring stuff…

    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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