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Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars. Their initial overarching biosimilar guidelines were recently updated in 2014.[1] Large portions of these EMA guidelines have been adopted by countries around the world, including: Australia, New Zealand, Canada, Japan, Korea, Singapore, South Africa and Switzerland. And while it took 5 years to get approval of the first biosimilar in the United States, the first biosimilar therapeutic was approved in one year after the regulatory guidelines were released.

Adoption of biosimilars in the European Union (EU) has been mixed, ranging greatly between countries and between products. This is because while the regulatory authorization is provided centrally by the EMA, each country retains control over substitution policies.[2] For example, a recent study by the IMS Institute for Healthcare Informatics found that biosimilar penetration in 2013 for G-CSF (filgrastim) ranged from 2% of treatment days in Belgium to nearly 100% in Croatia, Czech Republic, Hungary, and Romania.[3] The IMS study attributes differences in the uptake of biosimilars—and differences in price competition—to local practices, practices in turn influenced by national funding schemes and the actions of payers.[4]

The most impressive uptake of biosimilars has been in Scandinavia. In two years post-approval, biosimilar infliximab (Remsima) has garnered about 93% of the market share in Norway, 96% of the market share Denmark, and 88% in Finland.[5] The high uptake in these countries is likely due to strong financial incentives for switching to biosimilars and hospital leaders and physicians often pushed for their wider use. Sweden though is a different case where biosimilars hold only 33.5 percent of the market.[6] There though, Sweden's Medical Products Agency has publicly opposed switching.

Similar to the US, to gain marketing authorization in Europe, biosimilars need to demonstrate similar quality, safety, and efficacy to an EU-approved reference product. Unlike the US however, there is no provision for interchangeability – with these decisions settled by the national regulatory authorities across Europe.

Most recently, in May 2017 the EMA and the European Commission published an information guide for healthcare professionals on biosimilar medicines with the goal of providing healthcare professionals with reference information on both the science and regulation underpinning the use of biosimilars.[7]

To date, there are 35 biosimilars approved for use in the EU.


[1] http://www.ema.europa.eu

[2] https://www.biologicsblog.com/ten-years-of-biosimilars-in-europe/

[3] https://www.pbwt.com

[4] https://www.biologicsblog.com/ten-years-of-biosimilars-in-europe/

[5] Id.

[6] Id.

[7] http://www.ema.europa.eu

© 2017 Sterne Kessler

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About this Author

Paul Calvo, Intellectual Property Attorney, Sterne Kessler Law Firm
Ph.D. Director

Dr. Calvo, a director in the Biotechnology/Chemical Group, represents a diverse group of U.S. and international companies innovating in the biotechnology and pharmaceuticals industries.  He provides counsel with regard to global patent portfolio strategy, licensing, patent validity, infringement, and design around strategies.  Dr. Calvo is experienced in U.S. and international patent procurement and enforcement matters (particularly patent prosecution and oppositions), FDA/ANDA practice, technology transfer, invalidity, noninfringement, freedom-to-operate and patentability opinions, and...

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