Drug Design, Development and Therapy

The European Medicines Agency defines a biosimilar as a biological medicine that is similar to another biological medicine already authorized for use. A regulatory framework to ensure high-quality biosimilars has been established in Europe since 2005 and is monitored and updated on an ongoing basis. The guiding principle of a biosimilar development program is to establish similarity between the biosimilar and the reference medicine by the best possible means, ensuring that the proven safety and efficacy of the reference medicine also applies to the biosimilar. The credibility of the scientific basis behind the biosimilar concept, and quality of regulatory decision-making, is demonstrated by the successful approval and clinical use of 20 biosimilar medicines since 2006 when Omnitrope^® was the first biosimilar to be approved.