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 second 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.

The main objectives of the 2016 multi-stakeholder workshop on biosimilars were to present an update on the impact of biosimilars competition and provide an opportunity for gathering all relevant interested stakeholders to facilitate an exchange of information and experiences, as well as to launch the updated version of the Question and Answers document on biosimilars for patients and doctors.

The following series of articles present the subjects discussed during the 2016 multi-stakeholder workshop on biosimilar medicinal products.

Related articles
Revised Q&As on biosimilars for patients

Closing the information gap for biosimilars

National experience with biologicals, including biosimilars

References
1. European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs. Second multi-stakeholder workshop on biosimilar medicinal products; 20 June 2016; Brussels, Belgium.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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