[Biosimilars, the journey has begun].

According to the European Medicine Agency, a "biosimilar" is a biological medicinal product that contains a version of the active substance of an original biological medicinal product (reference or innovative medicinal product) that has been authorized in the European Economic Area. The similarity to the reference medicinal product in terms of quality, biological activity, safety and efficacy needs to be set on a comprehensive comparability basis. The generic standard approach (demonstration of bioequivalence with a reference medicinal product by appropriate bioavailability studies), which is applicable to a wide range of chemically derived medicinal products, is not sufficient to prove the similarity of biotechnology derived products due to their structural complexity.