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  • Open Access

Biosimilar medicines: creating sustainable competition in an era of a new patent cliff in biological medicines

Journal of Pharmaceutical Policy and Practice20158 (Suppl 1) :P28

  • Published:


  • Price Model
  • Generic Medicine
  • Price Competition
  • Pharmaceutical Market
  • Total Market

For many years European governments have sought to ensure a high degree of competition in off-patent pharmaceutical markets in order to generate price competition - and consequently benefits such as improved patient access or savings for payers after patent expiry. The pharmaceutical industry believes that access to valuable new treatments and post-exclusivity competition are essential for the sustainability of healthcare systems.

Biological medicines have become increasingly important over the last years. Twenty-seven per cent of pharmaceutical sales in Europe come from biological medicines. This market grew by 5.5% vs. a total market growth of 1.9% in value sales between 2012 and 2013. Many of Europe's top selling biologic molecules are facing patent expiry by 2020[1].

Most biological medicines come at a high cost and governments have difficulty in coping with these costs in their constrained pharmaceutical budgets, especially in current times of austerity. To date, biosimilars account for less than 0.5% of the $221 billion market of biological medicines worldwide. Biosimilars can bring huge savings for payers, and will increase the access to medicines for patients who could not otherwise afford treatment[2].
Figure 1
Figure 1

The biologics Market - IMS Health Thought Leadership, September 2013

Governments must realize that biosimilar medicines are different to generic medicines and as such a unique approach is needed. By applying the generic pricing model to biosimilar medicines, governments risk marking the biosimilar market unsustainable and patients and payers will no longer benefit.

Authors’ Affiliations

European Generic and Biosimilar Medicines Association, Brussels, 1000, Belgium


  1. IMS Institute: Assessing biosimilar uptake and competition in European markets. 2014Google Scholar
  2. Matti Aapro MD: Biosimilars in oncology: current and future perspectives. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013, 2 (2): 91-3.View ArticleGoogle Scholar


© Baelen 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.