Information for medicine users

The active substance in a biological medicine is a biological substance. A medicine similar to the original biological medicine is called a biosimilar.

A biological medicine is usually administered intravenously, or as a subcutaneous injection. Vaccines are biological medicines as well.  

As a general rule, a biological medicine only affects those cells or tissues that have the intended target structure. For this reason, biological medicines are often referred to as precision medicines. 

For more information on biological medicines, visit Fimea's webpage "Biological medicinal products".

Biosimilars are biological medicines. A biosimilar is as effective and as safe as the original biological medicine. It contains the same active substance as the original biological medicine, but a different version of it. 

The administration devices for the original biological medicine and its biosimilar may differ. However, the administration devices of interchangeable preparations are sufficiently similar so that the substitution can be carried out safely after advice from the pharmaceutical personnel of the pharmacy. If the device is not used properly, the medicine dose may be incorrect or the administration device may become damaged. 

Pharmacies provide guidance on the use of administration devices. Patients are encouraged to discuss matters related to pharmacotherapy with the attending body.

For more information about biosimilars, see Fimea's website.

Examples of diseases treated with biological medicines are diabetes, rheumatic diseases, psoriasis, inflammatory bowel diseases, asthma and cancer. Biological medicines are also used to prevent and treat venous thrombosis.

Biological medicines are often expensive. Drug substitution for biological medicines increases price competition and reduces drug reimbursement costs. The wider adoption of biosimilars is estimated to achieve annual savings of millions of euros in state drug reimbursement costs.

They are more complex in structure than conventional chemical medicinal products. Their manufacturing methods are challenging and time-consuming.

Once the patents of the original biological medicine has expired, a biosimilar can be developed using information partly obtained from the original biological medicine. Development of a biosimilar is therefore faster and cheaper and consequently, the price of the biosimilar is usually lower.

The automatic substitution scheme will be extended to biological medicines in stages starting from 1 April 2024.  

The schedule for automatic substitution of biological medicines in pharmacies:

• 1 April 2024 enoxaparin preparations
• 1 January 2025 all biological medicines except insulins
• 1 April 2025 insulin glargines
• 1 January 2026 other long-acting insulins

Note: Short-acting insulins are not a part of the automatic substitution scheme. Biological medicines for patients under the age of 18 will not be substituted at a pharmacy.

The need for substitution will be checked at a pharmacy every six (6) months. Biological medicines for patients under the age of 18 will not be substituted with another eligible preparation at a pharmacy. 

As a user of a biological medicine, you can prohibit the automatic substitution at a pharmacy if you wish. However, if the medicine you are prescribed is more expensive than its cheaper alternative, reimbursement will be paid according to the reference price of the cheaper medicine. In other words, if you want to continue using the more expensive medicine in your prescription, you will have to pay the difference between the price of the medicines yourself.

Your physician may prohibit substitution on medical or therapeutic grounds. If your physician prohibits substitution, he or she must record the prohibition in the prescription. You will then get a reimbursement for the price of the prescribed medicine.

For more information on the reimbursement status of medicines, see Kela's website.

Since 2017, physicians have had a statutory obligation to prescribe the most affordable biological medicine suitable for the patient's care.