The scope and requirements related to preclinical and clinical studies of a new medicinal product, including biotechnological and biosimilar products.

The article presents an outline of the requirements concerning the planning of preclinical and clinical studies, necessary for the legal approval of a medicinal product. It describes the clinical research plan of innovative and generic pharmaceutical products, taking into account the specific situations in which the assessment of biological equivalence of a generic product is not possible based on pharmacokinetic parameters. The article also discusses the guidelines which determine the scope of studies which are necessary in the process of registration of biotechnological and biosimilar products.