Biological and biosimilar medicinal products

Updated 08 July 2016

Biological medicinal products

A biological medicinal product differs from other types of medicinal products in that it is made by or derived from a biological source (from humans, animals or plants) or by way of genetically engineering methods. The vast majority of biological medicinal products used today are made by way of genetic engineering using mammal cells, yeast or bacteria to produce the drug molecule. A biological medicinal product often has a more complicated molecular structure than a synthetically (chemical, non-biological) made product.

Biosimilar medicinal products

A biosimilar medicinal product is a new version of an existing biological medicinal product (the reference medicinal product) that must have been authorised (in the EU) for at least 10 years. Biosimilar medicinal products may have minor differences in the molecule compared to the original version of the medicinal product, but these differences must not influence the efficacy and safety (adverse reactions) of the biosimilar version, compared with the original biological medicinal product.

The Danish Medicines Agency has increased focus on biological and biosimilar medicinal products

In the time ahead, the Danish Medicines Agency will focus on biological and biosimilar medicinal products. We increase our focus because this type of medicinal products is in development - new biological medicinal products are continuously being developed offering new or improved treatment options within growth hormones, cancer, diabetes and arthritis. At the same time, we expect that more biosimilar medicines will be developed when patents for the biological medicinal products expire in the years ahead.

Action plan to ensure monitoring of biological and biosimilar medicinal products

When a new medicinal product is introduced on the market, we always pay special attention to the medicinal product.

To ensure a targeted and product-specific monitoring of new biological and biosimilar medicinal products and ultimately safe treatment of patients, the Danish Medicines Agency and the Danish Ministry of Health have prepared an action plan.

The action plan includes four focus areas:

  1. Specific activities promoting monitoring on product level.
  2. Information efforts to improve healthcare professionals’ understanding of product-specific monitoring and citizens’ safety when using the products.
  3. Launch of digital solutions at hospitals and in medical practices to ease healthcare professionals’ reporting of adverse reactions.
  4. Special focus at the Danish Medicines Agency on monitoring the safety of using these medicinal products.

The plan will be implemented in a collaboration between the Danish Medicines Agency and a working group with representatives from Danish Patients, the Danish Medical Association, the Danish Association of the Pharmaceutical Industry, the Danish Generic Medicines Industry Association, the Danish Association of Parallel Importers of Medicine and Danish Regions.

Evaluation of the action plan will take place in April 2016 and at the end of 2016. See the entire action plan (in Danish).