A biological medicinal product (hereon referred to as ‘biological’) is a medicinal product that contains an active substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physio-chemical-biological testing, together with the production process and its control [Directive 2001/83/EC, Annex 1, Part I, Section 184.108.40.206(b)].
Biologicals encompass a very wide and diverse array of medicines. These include medicinal substances derived from blood and plasma, biotechnology-derived medicines (e.g. using recombinant DNA technology), all types of prophylactic vaccines and advanced therapy medicinal products (ATMPs). This GVP Considerations Chapter does not apply to vaccines and ATMPs as separate specific guidance already exists for these products (see GVP Considerations P.I. and the Guideline on Safety and Efficacy Follow-up and Risk Management of Advanced Therapy Medicinal Products1).
Unless specified otherwise in particular Sections, this Chapter applies to all biological medicinal products regardless of the regulatory pathway of approval or market exclusivity status, i.e. it applies to reference biological medicinal products (hereafter referred to “reference products”), to ‘similar biological medicinal products’ (hereafter referred to as ‘biosimilars’) and to products which contain the same or closely related active substance but not authorised as biosimilars (e.g. different versions of interferon beta-1a, factor VIII or normal human immunoglobulin) (hereafter referred to as ‘related products’).
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised reference product in the EEA, 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 Guideline on Similar Biological Medicinal Products2).