With the aim of encouraging equitable and timely access to biosimilars in Europe, the European Commission (EC) held its third workshop on biosimilars in Brussels, Belgium on 5 May 2017 [1].
Since 2010, a multi-stakeholder dialogue and co-operation at European level has been put in place under the Process on Corporate Responsibility/Access to Medicines in Europe including a Working Group on Market Access to and Uptake of Biosimilar Medicinal Products. The multi-stakeholder workshop held in Brussels was the third follow-up event to the activities related to biosimilars under the Process.
The EC approved its first biosimilar Omnitrope (somatropin) back in 2006 [2]. But besides regulation and market approval the EC (Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs) also aims to enhance collaboration between all interested and concerned stakeholders (patients, physicians and other healthcare professionals, payers, the Member States’ competent authorities and the pharmaceutical industry) in order to find common non-regulatory approaches for more timely, equitable access to and informed uptake of biosimilars after their marketing authorization.
This so called ‘multi-stakeholder approach’ helps to build a common understanding and trust between doctors and patients, payers and the commercial operators.
Over the last three years, the workshops have evolved from an initial taking stock of the situation and building on the positive momentum from the Process on Corporate Responsibility to a focus on real-world experience sharing, unbiased communication and patient involvement, empowerment and education. One major outcome has been the consensus Q&A document on biosimilars for patients, which was made available in 23 languages in November 2017 [3].
The main objectives of the 2017 multi-stakeholder workshop on biosimilars were to present an update on the impact of biosimilars competition and provide an opportunity for stakeholders to exchange information and experiences, as well as to launch the new European Medicines Association and European Commission communication guide on biosimilars for healthcare professionals.
The following series of four articles present the subjects discussed during the 2017 multi-stakeholder workshop on biosimilars.
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References
1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Multi-stakeholder Workshop on Biosimilar Medicinal Products; 5 May 2017; Brussels, Belgium.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. EC publishes biosimilar Q&A doc for patients in 23 languages [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jan 19]. Available from: www.gabionline.net/Biosimilars/General/EMA-publishes-biosimilar-Q-A-document-for-patients-in-23-languages
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1. real-world experience sharing
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