IS GENERIC SUBSTITUTION A POLICY BLUEPRINT FOR BIOSIMILAR SUBSTITUTION IN COMMUNITY PHARMACY?
Author(s)
Sabine Vogler, Dr, Valentin Kandler, ., Verena Knoll, MA, Margit Gombocz, BA, Friederike Windisch, Mag. (FH), Melanie Walter, PhD, Katharina Kieslich, PhD.
Pharmacoeconomics, Gesundheit Osterreich GmbH (GÖG) / Austrian National Public Health Institute, Vienna, Austria.
Pharmacoeconomics, Gesundheit Osterreich GmbH (GÖG) / Austrian National Public Health Institute, Vienna, Austria.
OBJECTIVES: Generic substitution is a well-established demand-side policy in several countries. With increasing market entry of biosimilars, which are off-patent follower biological medicines, policymakers explore transferability of similar substitution practices for biosimilars in community pharmacy. The study examines biosimilar substitution in community pharmacy compared to generic substitution and reviews recent developments.
METHODS: The study covers 50 countries, thereof 42 countries of the WHO European Region. The studied countries comprise all 27 European Union member states, the four countries of the European Free Trade Association, most Western Balkan countries and some countries in Central Asia. Countries from other regions include Australia, Brazil, Canada, Republic of Korea, Saudi Arabia, and South Africa. Data was collected as of March 2026, as well as for previous years starting from 2010. Information was obtained from resources of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network of competent authorities, to which all countries studied are members. For the 2026 update, PPRI network members were asked to provide information in the “PPRI Indicators” database.
RESULTS: While 47 of the 50 countries studied allow generic substitution, only 24 countries have additionally introduced biosimilar substitution. 21% of the countries with biosimilar substitution request mandatory substitution, whereas this figure amounts to nearly 30% regarding generic substitution. Biosimilar substitution was introduced in a few countries rather recently (e.g., Norway - 2021; France - 2022; Finland, Germany and Switzerland - 2024). It was usually being gradually implemented, with the introduction of substitution for selected biological substances at different points in time.
CONCLUSIONS: Over the years, policymakers appeared to have been hesitant in introducing biosimilar substitution. However, recent changes have been observed in several countries. Generic substitution probably served as policy blueprint, but unique characteristics associated with biosimilars may have limited transferability and therefore may cause slower implementation.
METHODS: The study covers 50 countries, thereof 42 countries of the WHO European Region. The studied countries comprise all 27 European Union member states, the four countries of the European Free Trade Association, most Western Balkan countries and some countries in Central Asia. Countries from other regions include Australia, Brazil, Canada, Republic of Korea, Saudi Arabia, and South Africa. Data was collected as of March 2026, as well as for previous years starting from 2010. Information was obtained from resources of the Pharmaceutical Pricing and Reimbursement Information (PPRI) network of competent authorities, to which all countries studied are members. For the 2026 update, PPRI network members were asked to provide information in the “PPRI Indicators” database.
RESULTS: While 47 of the 50 countries studied allow generic substitution, only 24 countries have additionally introduced biosimilar substitution. 21% of the countries with biosimilar substitution request mandatory substitution, whereas this figure amounts to nearly 30% regarding generic substitution. Biosimilar substitution was introduced in a few countries rather recently (e.g., Norway - 2021; France - 2022; Finland, Germany and Switzerland - 2024). It was usually being gradually implemented, with the introduction of substitution for selected biological substances at different points in time.
CONCLUSIONS: Over the years, policymakers appeared to have been hesitant in introducing biosimilar substitution. However, recent changes have been observed in several countries. Generic substitution probably served as policy blueprint, but unique characteristics associated with biosimilars may have limited transferability and therefore may cause slower implementation.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HPR114
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care, Medical Technologies
Topic Subcategory
Reimbursement & Access Policy
Disease
Biologics & Biosimilars