欧洲生物仿制药竞争的影响

The Impact of BiosimilarCompetition in Europe January 2026 MAX NEWTON,Principal, Global Strategic Partners, IQVIAKELSEY STODDART,SeniorConsultant, Global Supplier & Association Relations, IQVIAAURELIO ARIAS,Director, Global Thought Leadership, IQVIA Table of contents Introduction1IQVIA observations21. Pipeline42. Commercial attractiveness63. International competitiveness94. Access inequality105. Advanced planning14Methodology16Country and product segment KPIs18Granulocyte-Colony Stimulating Factor (GCSF)18Anti-Tumour Necrosis Factor (Anti-TNF)20Insulins22Oncology24Parathyroid hormone (teriparatide)26Ophthalmology28Appendix30EMA list of approved biosimilars30List of biosimilars under review by EMA36References37About the authors38Find out more39 Introduction The 11th edition of the ‘Impact of Biosimilar Competition in Europe’ reportbuilds upon the perspectives from last year’s publication and provides aforward-looking view on the upcoming opportunities and challenges forbiosimilar competition in Europe. Biosimilars continue to play a critical role in the European healthcare systemby generating savings for payers, creating headroom for innovation, andexpanding access to biologic therapy for patients. Since the first biosimilarwas launched in 2006, biosimilar medicines have become a core componentof an effective healthcare system. However, the biosimilar pipeline signalsfuture headwinds, which have been highlighted in previous reports andremain relevant today. The report consists of novel observations on market conditions for 2025,and a streamlined set of Key Performance Indicators (KPIs) to monitor theimpact of biosimilars in 23 European markets. Previous observations remainrelevant and have been refined or referenced to align with the report’sapproach of sharing novel observations on the impact of biosimilar in theEuropean healthcare system. This year’s report streamlines the KPI section byfocusing on product segments that experienced initialbiosimilar entry within the past ten years and haveshown recent market changes. The KPIs describe theeffects on price, volume, and market share followingthe arrival of biosimilar competition in Europe. Thereport has been a longstanding source of informationon the status of the biosimilars market. The reportcontinues to add and track new therapy areas in orderto maintain its relevance. This means that previousdefinitions are refined to make them representativeof the current environment, building on the 2020 (6th)report which permitted the classification of historicdynamics in the market, and allows policymakers,national competent authorities, patient groups, andindustry to view the market with greater granularity. This report has been prepared by IQVIA with initialcontributions on defining the KPIs from EFPIA,Medicines for Europe, and EuropaBio. The observationshave been developed solely by IQVIA based on thedata and analyses performed. The information andviews set out in this report are those of its authors.The European Medicines Agency (EMA) has a centralrole in setting the rules for biosimilar submissions,approving applications, establishing approvedindications, and monitoring adverse events, and ifnecessary, issuing safety warnings. We have, whenappropriate, quoted their information and statements. IQVIA gratefully acknowledges the contributions ofthose who have supported the development of thisseries over the years, notably: Marco Travaglio,Michael Kleinrock, Urvashi Porwal, Kirstie Scott,Mohit Agarwal, Siobhan Palmer, Sourish Rath andmany others. high-growth newcomers to established playerssupported by continued acceptance of the principlesof interchangeability and the value biosimilars providewithin the system. IQVIA observations Background Biologic medicines continue to play an importantrole in the EU pharmaceutical market, representing44% of total value at list prices (referring to bothoriginator biologics and biosimilars) (Exhibit 1).The continued launch of new biologic therapies,significant growth in established brands, and therecognition of biologics as advanced treatmentoptions are the key drivers behind the growing shareof biologic spending in Europe. This has resulted insustained double-digit growth for biologics over thepast 5 years, and higher annual growth rates thanother market segments, such as small molecules. Since the creation of this series of reports in 2015,IQVIA has provided observations on the biosimilarmarket in Europe (Exhibit 2). Each year the reportaims to provide novel insights on the market, howeverprevious years’ insights remain valid and are referencedfor posterity. These include past observations, such aschanging originator strategies (2019), the estimatesof the net savings as a proportion of healthcareexpenditure (2020), the location of emerging biosimilarmanufacturers (2021), the growing disparity in access(2022), and the biosimilar void (2023). Historically, the themes of these observations havebeen around savings, p