A European pharmaceutical strategy promoting generics and biosimilars

Generics/General | Posted 08/01/2021 post-comment0 Post your comment

The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.


This pharmaceutical strategy aims to ensure affordable, accessible, innovative and safe medicines are available to all. In addition, it hopes to support the European Union’s (EU) pharmaceutical industry by fostering competitiveness, innovative capacity and sustainability. The strategy was also developed to be future-proof and crisis-resilient and will lead to the creation of a strengthened European Health Union with robust supply chains. It draws on lessons learnt from the COVID-19 pandemic to help ensure the pharmaceutical sector has security of supply and is prepared for future health crises.

The EU strategy places emphasis on improving access to generic, biosimilar and value-added medicines. Here, there will be support for targeted policies to stimulate generics and biosimilars competition. This will involve more strict application of EU antitrust rules to prevent companies that hold drug patents from hindering entry or expansion of generics or biosimilars competitors.

The EU will take certain pharmaceutical industry related actions in 2022 and among those possible, it is proposed that the EU may remove barriers that delay generics market entry. In addition, it will increase their uptake by health systems and create clearer provisions to conduct clinical trials on patented products to aid generics marketing authorization applications. By this time, it is also thought that there will be a review of the incentives and obligations of pharmaceutical companies to facilitate wider drug distribution and competition. This could also require companies to make their patented drugs available in all EU Member States, including those that are small and of less economic interest to companies.

Overall, to facilitate access to generics and biosimilars the strategy needs to:

  • Ensure that off-patent medicines are always available and causes of medicine shortages are identified and eliminated
  • Ensure access to generic, biosimilar and value-added medicines for all patients, by removing barriers to off-patent medicines
  • Modernize through digitalization of medicine regulatory systems to speed up processes and provide improved information on products and their supply, that is harmonized across Europe
  • Support resilient manufacturing and industrial policy that increases competitiveness, creates jobs and improves supply resilience.

The strategy also highlights the reality of unmet medical needs in Europe and hopes to stimulate innovation and development in these areas. These include medicines for neurodegenerative conditions and certain rare diseases and cancers. There are also some drug shortages, such as certain antibiotics, and drugs for children and for rare diseases. Such shortages were exacerbated during the first wave of the COVID-19 pandemic due to export bans and trade restrictions and, in light of this, the strategy aims to develop Europe’s strategic autonomy.

Related articles
Reforms to health policy needed in Europe

Challenges faced by biosimilar orphan drugs in European health systems

The landscape for orphan drugs in Europe

Biosimilars in oncology in Europe


To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.



Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latin América.

Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa. 

1. European Commission. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Pharmaceutical Strategy for Europe. {SWD(2020) 286 final} [homepage on the Internet]. [cited 2021 Jan 8]. Available from: https://ec.europa.eu/health/sites/health/files/human-use/docs/pharmastrategy_com2020-761_en.pdf

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 © 2021 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Related content
Generic drug growth in Brazil and Venezuela
53 MD002445
Generics/General Posted 15/09/2023
Pharmaceutical manufacturing companies in Brazil
91 AA007225
Generics/General Posted 26/08/2022
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