This article has been published on Labiotech.eu

During the past decade, Europe saw the emergence of a new type of drug: biosimilars. The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The European Commission approved the first biosimilar, Omnitrope (Somatropine) from Sandoz, in 2006.

How are these new drugs different from traditional generics? The following knowledge has been elaborated as a result of exchanges with experts from more than 20 organizations, including the European Medicine Agency (EMA).

A biosimilar is a biological medicine that is similar to another already authorized for use, which is known as the “reference medicinal product”. Currently, we have 23 biosimilars approved in Europe, including Benepali and Inflectra, and they represent 7 active substances.