What pricing and reimbursement policies to use for off-patent biologicals? – Results from the second EBE biological medicines policy survey

Category: Original Research
Author(s): , ,
Visits: 137 total, 5 today
Keywords: Biological medicines, biosimilars, off-patent market, pricing and reimbursement policy

Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the first biosimilar was approved in the EU, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off-patent biologicals.
Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and developed by the EBE Biosimilars Working Group. It contained 44 fields about 8 policy areas: Availability of biological medicines, tendering, Health Technology Assessment (HTA), INN prescribing, Internal Reference Pricing (IRP), Substitution, Interchangeability and Quotas.
Results: Responses from all national trade associations have been received. The majority of the 32 countries of the survey have specific policies for off-patent biologics in place and therefore take account of the specificities of biologics. Nevertheless, variations exist and reflect the responsibilities in healthcare policy-making in Europe. In the majority of countries, treatment decisions remain in the hands of physicians. Compared to the first EBE survey, shifts have been seen in the areas of substitution and interchangeability.
Conclusion: The second EBE survey on biologics policies indicates that nearly all jurisdictions have policies in place that reflect the different nature of biological medicines. However, policies and their implementation vary among different jurisdictions.


Jean-Baptiste Reiland, Project Manager, Global Public Affairs, Sanofi
Alexander Roediger, MA, Executive MBA, Policy Lead Oncology for Europe, Middle East, Africa and Canada (EMEAC) at MSD
Barbara Freischem, Executive Director, European Biopharmaceutical Enterprises (EBE)

Subscribe now to GaBI Journal to view full information of this article to be published in the next journal issue.

Go Back Print

Leave a Reply