BUSINESS
    Japan’s 1st Xolair Biosimilar Finally Set for December Launch after Delays
    By Shinya Sato October 23, 2026
    Celltrion Healthcare Japan is preparing to launch Japan’s first biosimilar of Novartis Pharma’s Xolair (omalizumab) in late December — four months past the standard timeline — following delays linked to patent-related restrictions and stronger-than-expected demand.The…

    LATEST

    PHP Security Flaws Trigger Website Shutdowns Across Japan Pharma Sector
    October 23, 2026
    Japanese pharmaceutical manufacturers, wholesalers, and regulatory bodies rushed to apply security patches and temporarily shut down websites and portals on October 21-22 following the disclosure of critical vulnerabilities in the widely used PHP programming language.The panic stems from emergency security…
    Panel Backs RSV Antibodies for Japan’s Routine Immunization Program
    October 23, 2026
    A Japanese health ministry panel concluded on October 22 that using two anti-RSV antibody products under the national immunization program (NIP) is scientifically sound, paving the way for their potential inclusion in routine RSV prevention…
    New York Note - 1: JETRO’s Role in Connecting Japan with the World
    October 23, 2026
    PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…

    Cost Effectiveness Assessment (2025-)

    LDP Health Chief Demands CEA Overhaul, Backs Freeze on Price Cuts
    By Takashi Ebisawa

    Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…

    COMMENTARY

    Lp(a) Drugs Face Next Test in Quest to Cut Cardiovascular Risk
    By Koji Shimomura

    Global drug makers are forging ahead with therapies targeting lipoprotein(a), or Lp(a), a promising new approach to reducing cardiovascular risks.…

    Off-Year Drug Price Revisions

    Japan to Weigh Necessary Measures for FY2027 Revision: PM

    Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…

    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…

    COLUMN

    Outside the Bubble: Lunch with Pharma Delegates
    By Philip Carrigan

    The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…

    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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