Internal Market, Industry, Entrepreneurship and SMEs

Corporate responsibility in the pharmaceutical industry

Corporate responsibility in the pharmaceutical industry

The von der Leyen Commission transferred all the responsibilities concerning pharmaceuticals to the Directorate-General for Health and Food Safety.
This webpage is no longer being updated.

Market access for biosimilars

During the 'process on corporate responsibility', the working group on 'access to and uptake of biosimilars' took stock of the availability of biosimilar medicinal products in national markets. The group also defined the conditions for their informed uptake and adequate patient access.
They identified clear and unbiased information from an independent and reliable source as one of the key elements for adequate and informed uptake of biosimilar medicines. The 2013 document on biosimilar medicinal products informs all stakeholders on the scientific concept of biosimilars, their approval process, and their safety and efficacy.

Specific and recently revised information on biosimilars for patients is available in the 2016 document on biosimilar medicines. In 2017, a new information guide for healthcare professionals was published in cooperation with the European Medicines Agency.

A 2017 report conducted by QuintilesIMS on behalf of the European Commission gives insights on the impacts of the increased biosimilar competition in Europe.

Follow-up activities to the ‘process on corporate responsibility’
Multi-stakeholder workshop 'access to and uptake of biosimilar medicinal products'
Second multi-stakeholder workshop on biosimilar medicines
Third multi-stakeholder workshop on biosimilar medicines
Fourth multi-stakeholder workshop on biosimilar medicines
Fifth multi-stakeholder workshop on biosimilar medicines

Documents