BIOSIMILAR AVAILABILITY AND UPTAKE ACROSS SIX EUROPEAN COUNTRIES: UNEVEN UTILIZATION DESPITE EXPANDING ACCESS
Author(s)
Kim J. Schmidt, MSc1, Mareike Konstanski, MSc2, Jessica Schepis Martinez, MSc3, Dominik Elsner, MSc4, John Nikolettos, PhD5.
1Cencora, Milan, Italy, 2Cencora, Hannover, Germany, 3Cencora, Bern, Switzerland, 4Cencora, Gothenburg, Sweden, 5Cencora, Athens, Greece.
1Cencora, Milan, Italy, 2Cencora, Hannover, Germany, 3Cencora, Bern, Switzerland, 4Cencora, Gothenburg, Sweden, 5Cencora, Athens, Greece.
OBJECTIVES: The number of biosimilars authorized in the European Union (EU) nearly doubled between 2023 and 2026. However, cross-country variation persists in both availability and uptake. This study assessed biosimilar availability - defined as active commercialization and reimbursement - and uptake - defined as utilization share across all biological products with available biosimilars - in France, Germany, Greece, Italy, Spain, and Sweden.
METHODS: Country-level data on commercialization and reimbursement of EU-authorized biosimilars were collected from national pharmaceutical databases in May 2026. Utilization data were identified via a targeted literature review conducted in local languages.
RESULTS: As of 12 May 2026, 25 biosimilar molecules (144 products) were authorized in the EU. Germany was the only country commercializing/reimbursing at least one product for all 25 molecules (120 products), while Sweden demonstrated the lowest coverage (17 molecules; 54 products). France, Greece, Italy, and Spain commercialized/reimbursed 86, 61, 78, 93 products, corresponding to 24, 18, 24, and 23 molecules, respectively. Despite broad reimbursement, Germany reported the lowest uptake (16% in 2024). Sweden showed the highest uptake (68% in 2025, up from 57% in 2024), followed by Spain (58% in 2025, up from 55% in 2024), Italy (51% in 2024), and France (35% in 2024). No uptake data were identified for Greece. Utilization patterns varied considerably by molecule and country. Full uptake (100%) was observed for infliximab in the French outpatient setting (2024), subcutaneous infliximab across all Italian regions (2025), epoetin zeta in Germany (2025), and adalimumab, etanercept, and pegfilgrastim in Sweden (2025). In Spain, pegfilgrastim, bevacizumab, filgrastim, and infliximab reached uptake close to 100% in 2025. No molecule-level data were identified for Greece.
CONCLUSIONS: Biosimilar availability and uptake remain heterogeneous across countries. Commercialization and reimbursement alone appear insufficient to ensure adoption; country-specific policies, including incentives, procurement mechanisms, switching strategies, and stakeholder confidence, are likely key drivers of utilization.
METHODS: Country-level data on commercialization and reimbursement of EU-authorized biosimilars were collected from national pharmaceutical databases in May 2026. Utilization data were identified via a targeted literature review conducted in local languages.
RESULTS: As of 12 May 2026, 25 biosimilar molecules (144 products) were authorized in the EU. Germany was the only country commercializing/reimbursing at least one product for all 25 molecules (120 products), while Sweden demonstrated the lowest coverage (17 molecules; 54 products). France, Greece, Italy, and Spain commercialized/reimbursed 86, 61, 78, 93 products, corresponding to 24, 18, 24, and 23 molecules, respectively. Despite broad reimbursement, Germany reported the lowest uptake (16% in 2024). Sweden showed the highest uptake (68% in 2025, up from 57% in 2024), followed by Spain (58% in 2025, up from 55% in 2024), Italy (51% in 2024), and France (35% in 2024). No uptake data were identified for Greece. Utilization patterns varied considerably by molecule and country. Full uptake (100%) was observed for infliximab in the French outpatient setting (2024), subcutaneous infliximab across all Italian regions (2025), epoetin zeta in Germany (2025), and adalimumab, etanercept, and pegfilgrastim in Sweden (2025). In Spain, pegfilgrastim, bevacizumab, filgrastim, and infliximab reached uptake close to 100% in 2025. No molecule-level data were identified for Greece.
CONCLUSIONS: Biosimilar availability and uptake remain heterogeneous across countries. Commercialization and reimbursement alone appear insufficient to ensure adoption; country-specific policies, including incentives, procurement mechanisms, switching strategies, and stakeholder confidence, are likely key drivers of utilization.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR110
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Biologics & Biosimilars, No Additional Disease & Conditions/Specialized Treatment Areas