Objective: 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 European Union, 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 was developed by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas.

Results:
 Responses were received from all national trade associations contacted. According to the responses, the majority of the 32 countries surveyed have specific policies for off -patent biologicals in place and therefore take account of the specificities of biologicals. 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 biological medicines 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.

Click here to read the full survey results.
09 May 2017 in Highlights