Going forward, companies no longer have to apply to the Danish Medicines Council when they want to introduce biosimilars.

Biosimilars with the same indication and route of administration as a medicinal product already recommended by the Danish Medicines Council can now be introduced without an assessment by the Danish Medicines Council. This means that if the Danish Medicines Council has issued treatment guidelines in this field, the biosimilar will automatically be part of the next Amgros tender and thus the subsequent pharmaceutical recommendation.

This was announced on the website of the Danish Medicines Council on 6 February 2023.

The reason for the Danish Medicines Council's new procedure is a statement from the European Medicines Agency (EMA) from autumn 2022, in which the EMA said that they now have so much experience with biosimilars that the EMA considers them to be interchangeable with the original medicinal products. See the EMA's Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU.

In addition to this, the Danish Medicines Council is also stating that the experiences with biosimilars in Denmark have been good over the last 10 years. The new procedure entered into force on 26 January 2023.

What are biosimilars?

A biosimilar is a new version of an already existing biological medicinal product (the reference medicinal product) which must have been approved in the EU for at least 10 years. There might be minor differences in the molecule in relation to the reference medicinal product; however, these differences must not have an impact on the efficacy and safety (adverse reactions) of the biosimilar version compared to the reference medicinal product.

Read the Danish Medicines Council’s announcement (in Danish).

Want to know more?

If you would like to hear more about the rules on the introduction of medicinal products, please contact Plesner’s Life Science team.