Biological medicinal products

Biological medicinal products

Biological medicinal product is a product, the active substance of which is a biological substance (Directive 2001/83/EC). A biological substance is a 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 physico-chemical-biological testing, together with the production process and its control. However, all substances extracted from a biological source are not biological medicinal products, for example antibiotics which are produced in yeast/mold or polysaccharides, which can be accurately analysed and for which there is no viral risk, are classified as chemical medicinal products.

Biological medicinal products include e.g. vaccines, blood products (e.g. coagulation factors), allergens and products manufactured using recombinant technology (proteins, e.g. insulin and antibodies). The newcomers of the group are so-called advanced therapy medicinal products (ATMPs): gene- and cell therapy medicinal products and tissue engineered products.

Biological medicinal products were previously developed mainly for rare diseases, but nowadays more and more of them are directed towards treatment of common diseases like diabetes, arthritis, inflammatory bowel diseases, asthma and cancer. Biological medicinal products are believed to hold significant position in future medication, as already half of the products under development are biological medicinal products.

The list of biological medicinal products can be found using FimeaWeb (choose classification: Biological medicinal products): FimeaWeb

Supervision of biological medicinal products

The supervision of biological medicinal products has always been under special attention in EU legislation, due to the fact that these products differ from other medicinal products with regards to their composition and manufacturing processes.  The active substances of biological medicinal products are often heterogeneous mixtures, because of their starting materials (live cells) and complex manufacturing and purification processes.

The marketing authorization applications (MAA) of biological medicinal products are handled solely through the centralized MA process, which is co-ordinated by the European Medicines Agency (EMA) in London. In addition to pharmacy and pharmacology, the supervision and evaluation of biological medicinal products is based on many other sciences like biochemistry, cell and molecular biology, microbiology, virology and immunology. For the regulation new scientific information is applied on a case by case basis, because the guidelines in this field are not very detailed. The assessment of the quality and manufacturing data of biological medicinal products is centered to Biologics Working Party (BWP) at the EMA, whereas the Committee for Human Medicinal Products (CHMP) has the overall responsibility of the MAA assessment.

Fimea continuously improves its´ know-how for the supervision of biological medicinal products and strives for efficient networking with external experts. For several biological products, the experts from Fimea have participated to classification, scientific advice and assessment of MA applications in centralized and MRP processes, including arbitration processes. The data requirements for MA applications are described in Directive 2001/83/EC, yet there are additional, special requirements for certain products, depending on their starting materials. For example, for products containing blood or other human tissues/cells specific EU requirements have been adopted in 2003 and 2004, respectively. Fimea experts have often played central roles when EU guidelines have been developed for biological and biotechnological products, the guidelines can be found from EMA website.

Starting from 1 April 2024, a biological medicine can be substituted at pharmacy with a more affordable alternative.