Key concepts

A reference product (or innovative product) refers to a medicinal product brought to the market by the developer of the active substance or a party authorised by the developer.

A biological medicinal product is a product whose active substance is a biological substance. A biological substance is a substance that is produced from a biological source and needs to undergo physicochemical and biological analyses, and whose production processes and their supervision need to be examined to describe the substance and determine the quality.

A biosimilar is a similar biological medicinal product containing a new version of the active ingredient of the original drug. Biosimilars are developed to be analytically similar and clinically equal to an original biological drug approved in the EU.

A generic product refers to a medicinal product that contains the same active substance as the reference product and whose strength and pharmaceutical form are also the same. The excipients and manufacturing methods of the products may be different. Their biological equivalence has been proven.

A parallel-import product is an innovative product imported by a parallel importer without a licence from the innovative manufacturer.

Generic substitution means the replacement by pharmacy personnel of the medicinal product prescribed by a doctor or a dentist with the cheapest or nearly cheapest generic product, biosimilar product or parallel-import product suitable for substitution.