10 years of biosimilars in Europe

12.04.2016 13:10

Exactly 10 years ago, on April 12, 2006, the first biosimilar was approved in the European Union. According to the Pro Biosimilars industry association, the great relevance of biosimilars for patient care and a sustainably financed healthcare system was also made clear in the pharmaceutical dialogue.

The first biosimilar on the European market was Omnitrope (active ingredient somatropin) from Sandoz/HEXAL in 2006. To date, the European Medicines Agency (EMA) has approved a total of 22 biosimilars, including Epoetine, Filgrastime, Follitropin and Insulin Glargine. With infliximab and etanercept, the first biosimilar monoclonal antibodies, the so-called second-generation biosimilars, have been available for care since February 2015 and February 2016, respectively.

“Biosimilars offer a fully-fledged therapeutic alternative to the reference product with the same quality, effectiveness and safety and, thanks to their price advantage, can help to give more patients access to modern therapies and at the same time keep the drug supply affordable in the long term. “It is all the more important that the relevance of biosimilars is reflected in the pharmaceutical dialogue and that the necessary framework conditions are addressed in order to leverage the potential of biosimilars,” said Dr. Andreas Eberhorn, Chairman of the Pro Biosimilars Working Group.