EC workshop on biosimilars aims to improve uptake

Home/Reports | Posted 24/02/2017 post-comment0 Post your comment

With the aim of encouraging timely access to biosimilars in Europe, the European Commission (EC) held its second Multi-stakeholder Workshop on Biosimilar Medicinal Products in Brussels, Belgium on 20 June 2016 [1].

Biologicals 2 V12K16

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2017 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010