Biological medicinal products

Due to its complexity, a biological medicinal product may not be characterised by testing the final product alone.

Biological medicinal products are often sensitive to changes in the manufacturing method. Small structural differences can be difficult to detect and therefore a description of the process and process controls are an important element to ensure the quality of the product.

The characterisation of a biological medicinal product therefore requires a combination of tests on the pharmaceutical substance and the finished product, as well as knowledge of the manufacturing process.

Examples of biological medicines:

• Vaccines
• Blood products/plasma derived medicinal products (e.g. albumin, immunoglobulins, coagulation factors).
• Antiserum (against different types of poison, e.g. snake poison)
• Polyclonal antibodies (e.g. anti-human thymocyte immunoglobulin)
• Monoclonal antibodies
• Enzymes
• Interferons
• Peptide hormones
• Peptides
• Some complex polysaccharides (e.g. heparins)
• Advanced therapies (gene therapy, somatic cell therapy or tissue-engineered products)

Examples of substances that are easy to characterise and therefore do not qualify as biological substances:

• Gelatine, magnesium stearate
• Dextrans, starches, single polysaccharides
• Amino acids, vitamins, antibiotics
• Synthetic peptides and synthetic oligonucleotides (RNA, DNA) such as aptamers and antisense, although they may be complex and difficult to characterise, do not count as biological substances since they are not of biological origin.

Application for authorisation

Application via centralised procedure

If the biological medicinal product is produced by one of the following methods, the application must be made through the centralised procedure:

• Recombinant DNA (recombinant proteins)
• Use of transformed cells
• Hybridomas and methods for monoclonal antibodies

Applications for the authorisation of medicinal products classified as advanced therapies are also submitted through the centralised procedure.

In addition, centralised authorisation for biological medicinal products that are not manufactured using the above methods (e.g. many vaccines, blood or plasma derived products, enzymes, heparins) may be applied for on a voluntary basis if they contain a new active substance or have a significant therapeutic, scientific or technological innovation or are of interest from a patient point of view.

For the types of biological medicinal products that need to be approved centrally, applications for variations, extension of existing authorisations for medicinal products (known as line extension), parallel distribution and biosimilars also need to be made via the centralised procedure.

Products not obliged to apply via centralised procedure

For biological products for which applications do not need to be submitted through the centralised procedure, applications for marketing authorisation in Sweden may be submitted via one of the national, mutual or decentralised procedures.