EMA: Biosimilar medicines

A similar biological or \'biosimilar\' medicine is a biological medicine that is similar to another biological medicine (the ‘biological reference medicine’) that has already been authorised for use. Biological medicines are made by a living organism, such as a bacterium or yeast, and can consist of relatively small molecules such as human insulin or erythropoietin or complex molecules such as monoclonal antibodies. Biosimilars can only be authorised for use once the period of data exclusivity on the biological reference medicine has expired. In general, this means that the biological reference medicine must have been authorised for at least 10 years before a similar biological medicine can be made available by another company.