Pharmacies are soon allowed to substitute a biological medicine with a more affordable alternative

From April 2024 onwards, a biological medicine prescribed to the patient can be substituted with a cheaper interchangeable medicinal product at the pharmacy. The aim of generic substitution is to increase price competition and reduce medicine reimbursement costs.  

Since 2017, physicians have had a statutory obligation to prescribe the most affordable biological medicine suitable for the patient's care. The substitution of biological medicines in pharmacies will be introduced gradually, starting from the beginning of April 2024, allowing the pharmacies to substitute biological medicines with more affordable alternatives. 

The original biological medicine and its biosimilar have equal therapeutic value

A biological medicine is a preparation whose active ingredient is a biological substance. A biological medicine is usually administered intravenously, or as a subcutaneous injection. Biological medicines and their biosimilars are used both for the treatment of rare diseases and for common ones, such as diabetes, rheumatism, and inflammatory intestinal diseases.  Prescriptions for biological medicines are only valid for one year at a time.

A biosimilar is a medicine that is as effective and safe as its original biological medicine.  It contains the same active substance as the original biological medicine. 

Generic substitution will be extended to pharmacies gradually

The first medicines to be included in the generic substitution scheme in April 2024 will be enoxaparin preparations for preventing and treating venous thrombosis. In January 2025, the substitution of biological medicines in pharmacies will be extended to biological medicines, such as those used for treating rheumatism, psoriasis, asthma and inflammatory bowel diseases.   

The substitution of insulin glargines used in the treatment of diabetes will begin in April 2025 and the substitution of other long-acting insulins in January 2026. Short-acting insulins are not a part of the generic substitution scheme. Biological medicines for patients under the age of 18 will not be substituted at a pharmacy. You can use the FimeaWeb search service to check what medicines are biological.

Device advice ensures safe drug substitution

The Finnish Medicines Agency Fimea creates a list of interchangeable biological medicines four times a year. 

The administration device of the original biological medicine might operate differently from that of the biosimilar. However, the administration devices of interchangeable preparations are so similar that the substitution can be carried out safely after advice from the pharmaceutical personnel of the pharmacy. Pharmacies provide guidance on the use of administration devices. Patients are also encouraged to discuss matters related to pharmacotherapy with the attending physician.

Substitution is expected to reduce medicine reimbursement costs

Biosimilars create price competition between biological preparations and can lead to significant savings in the state's medicine reimbursement expenses. In addition, biosimilars introduce more options for treating diseases and can thus improve the availability of biological medicines.

It is estimated that the wider introduction of biosimilars will result in annual savings of millions of euros in the state's pharmaceutical reimbursement costs.

Read more: 

Fimea: Substitution of biological medicines 
FimeaWeb search service 
Ministry of Social Affairs and Health: Prescriptions for biological drugs are only valid for one year at a time (29 November 2023) 
THL: The validity periods of prescriptions will change: Prescriptions for biological drugs will be valid for one year (15 November 2023, in Finnish)