REGULATORY
    Forxiga, Zytiga Seen Taking Biggest Hit by PMP Returns in FY2026
    By Shinya Sato December 5, 2025
    Six brand-name drugs are set to face additional price cuts in Japan’s FY2026 drug price revision next April due to returns of the price maintenance premium (PMP) following new generic or biosimilar entries, Jiho has…

    LATEST

    Eylea Bio-AG to Carry DME Indication Missing from Fuji’s Biosimilar Label
    December 5, 2025
    Bayer Yakuhin’s biologic authorized generic (bio-AG) version of Eylea (aflibercept) was added to Japan’s NHI price list on December 5 with a broader label than Fuji Pharma’s biosimilar — including diabetic macular edema (DME), which…
    Keytruda Extends Japan Sales Lead to 26 Straight Months in November: Encise
    December 5, 2025
    MSD’s anti-PD-1 antibody Keytruda (pembrolizumab) remained the top-selling prescription drug in Japan in November, marking its 26th consecutive month in the No. 1 spot, according to preliminary monthly snapshot data released by Encise on December 4.On an NHI price basis,…
    Vimpat Draws 10 Generic Entrants in December Listing; Forxiga Has Two, but Nipro AG Absent
    December 4, 2025
    Six APIs will see first-time generic entries in the next round of biannual generic listing on December 5, including 10 versions of UCB Japan’s antiepileptic Vimpat (lacosamide) and two of AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin),…

    COLUMN

    AI in HR: Navigating the Ethical Minefield
    By Philip Carrigan

    Let’s be real: even with the best intentions, AI systems can reflect our own unconscious biases. As Daniel Kahneman and Amos Tversky famously demonstrated in their groundbreaking work on Prospect Theory, humans are prone to cognitive biases that influence our…

    COMMENTARY

    MOF Autumn Proposals Signal a Shift from Drug Pricing to Cost-Sharing Reform
    By Ken Yoshino

    As Japan approaches the Fiscal System Council’s “autumn recommendation,” a notable shift is taking shape. The Ministry of Finance (MOF),…

    Chuikyo Debate on FY2026 Drug Pricing Reform

    Chuikyo Discusses Lower Prices for Low-Novelty Drugs, PMP Criteria, Re-Pricing
    By Ken Yoshino

    Japan’s drug pricing panel on November 19 discussed a wide range of potential pricing changes related to patent-protected medicines, including…

    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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