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Press release

Reference price groups for biologic medicines to be expanded on 1 April 2024

Published 14/2/2024

Substitution for biologic medicines will be expanded to cover the following products: 

  • Starting 1 April 2024, enoxaparin products and all other low molecular weight heparins belonging to the same category of medicines
  • Starting 1 January 2025, all other biologic medicines, with the exception of insulins
  • Starting 1 April 2025, glargine insulin products
  • Starting 1 January 2026, degludec insulin products and other long-acting insulin products

In the case of short-acting insulin products, generic substitution will continue to be possible only between substitutable direct-import, parallel-import and parallel-distribution products.

List of substitutable products

The Finnish Medicines Agency (Fimea) determines which biologic medicines are substitutable and assesses the equivalency of delivery devices. Fimea publishes a list of mutually substitutable medicinal products four times a year. The list that becomes effective at the beginning of April will be posted on the Fimea website by 15 February 2024.

Determination of reference price groups and reference prices

The Pharmaceuticals Pricing Board defines the reference price groups, the products included in the groups, and the reference prices. The reference price groups of biologic medicines are based on Fimea’s list and the price notifications submitted by marketing authorisation holders. Starting April 2024, a reference price group of biologic medicines can also consist of the original reference medicine and a biosimilar or of two biosimilars.

Substitution at the pharmacy

When dispensing substitutable biologic medicines, pharmacies must provide the purchaser with the advice needed for the safe and appropriate use of the medication and the delivery device. Fimea and Kela provide pharmacies with more detailed substitution guidelines for biologic medicines.

More information on generic substitution and the reference price system

Inquiries

  • List of substitutable medicines: laakevaihto@fimea.fi
  • Reference price groups, products included in the groups and reference prices: hila.stm@gov.fi
  • Price notifications from pharmaceutical companies and the determination of price bands:     laakevaihto@kela.fi
Last modified 14/2/2024