Biological medicinal product

A medicine that contains one or more active biological substances. A biological substance is produced by or extracted from a biological source and needs for its characterisation and the determination of its quality a combination of physico-chemical-biological testing, together with the production process and its control.
The following shall be considered as biological medicines
» immunological medicines and medicines derived from human blood and human plasma
» products developed by means of one of the following biotechnological processes: recombinant DNA technology, controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells, hybridoma and monoclonal antibody methods
» advanced therapy medicines.
Examples include proteins such as hormones (growth hormones, insulins, erythropoietins), enzymes that are naturally produced in the human body, or monoclonal antibodies, but also blood products, immunological medicinal products such as sera and vaccines, allergens, and advanced technology products such as gene and cell therapy products. Like all medicines, biological medicines work by interacting with the body to produce a therapeutic outcome, but the mechanisms by which they do this may vary from product to product and across indications. Biopharmaceuticals can be tailor-made to fit the desired target. Therefore the role of the physicians in treatment of patients with these complex medicinal products is particularly important. This definition only refers to biotechnology-derived medicines which, since 1995, must be assessed centrally by the European Medicines Agency (EMA) and in case of a positive scientific opinion adopted by the scientific committee, are subject to a formal decision process for marketing by the European Commission.
Synonym: biological medicine, biopharmaceutical

In German: Biologisches Arzneimittel / Biologikum
Arzneimittel, dessen Wirkstoff aus einer biologischen Quelle (lebende Zellen oder Organismen) hergestellt wird.

Last update: 7 June 2023

Source: Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001