Biosimilar medicinal product

A biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal) product in the European Economic Area, and which has shown similarity to the reference product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise (see EMA-CHMP Guideline on Similar Biological Medicinal Products Rev 1).

See also Biological medicinal product