Frequently asked questions about biological drugs and biosimilars

A biological medicine is a preparation whose active ingredient is a biological substance. A biological substance is a substance that is produced from a biological source and needs to undergo physicochemical and biological analysis, and whose production processes and their supervision need to be examined to describe the substance and determine the quality.

Directive 2001/83/EC

The active substances of biological medicines are often large molecules which are structurally more complex than the active substances of chemical medicines. A significant difference between traditional (chemically manufactured) and biological medicines is that usually biological medicines affect a cell by targeting a specific structure. These structures can include, for example, transmitter substances, protein structures and cell membrane receptors. The medicine is usually administered intravenously, or as a subcutaneous injection.

A biosimilar is a biological “copy medicine” containing a new version of the active substance of the original medicine. Biosimilars are developed to be analytically similar and clinically equal to an original biological medicine approved in the EU.

The development of a biosimilar medicine differs significantly from the development of an original biological medicine. The development begins with extensive characterisation of several originator batches by the biosimilar medicine developer. The aim is to determine the quality characteristics of the reference product and their inherent variation between production batches. Based on this information, the manufacturing process of the biosimilar product is designed in such a way that it will yield a medicine that is for all critical quality characteristics highly similar to the reference product. Once the development of the production process has been completed, similarity between the biosimilar and the reference product is demonstrated in extensive comparability studies.

Biosimilars create price competition among biological preparations.

Biosimilars bring more equally effective and safe options to the treatment of illnesses and in that way, they can improve the availability of biological medicines.

At the beginning of 2024, there were around 80 biosimilars on the market in the European Union, around 50 of which were available in Finland.

Biosimilars with a marketing authorisation can be found using the FimeaWeb medicines search, and a list of biosimilars available on the market in Finland can be found on Fimea’s website:

• FimeaWeb medicines search
• A list of biosimilars available on the market (in Finnish)

Yes, it is. A biosimilar contains the same active substance as the original medicine, even though there may be small differences among biological preparations. Thorough studies have been conducted to rule out the possibility that the small analytical differences between the biosimilar and the reference product could impact the effectiveness or safety of the medicines. The effectiveness and safety of a biosimilar are therefore the same as with the original medicine.

To avoid errors in dosage, a patient always needs to be instructed in the use of a required dosage device when starting to take a biological medicine, whether the original one or biosimilar on their own. The medicine can also be administered in a hospital as an intravenous infusion.

The safety of each medicine is monitored as long as it is available. Therefore, possible unexpected or severe side effects should be reported to pharmaceutical authorities.

When biosimilars become available after the expiration of the patent of the original medicine, price competition is expected between these comparable products. Consequently, the use of biosimilars is aimed at achieving savings without endangering the effectiveness and safety of the treatment.

The doctor always decides on pharmacotherapy; for instance, the doctor selects the medicine used to treat the illness. If a biological medicine is used for medicinal treatment, doctors are obliged to prescribe the most affordable biological medicine that can be used to treat the patient. 

Biological medicinal products may be substituted for a more affordable interchangeable medicine at a pharmacy. Fimea confirms the interchangeable drug list four times a year. Biological medicinal products for patients under the age of 18 will not be substituted at pharmacies.

Users of biological medicinal products may prohibit the substitution at the pharmacy. However, if the medicine they 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 the user wants to continue using the more expensive medicine in their prescription, they will have to pay the difference between the price of the medicines themselves.

The doctor may prohibit substitution on medical or therapeutic grounds. If the doctor prohibits substitution, they must record the prohibition in the prescription. The user 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.

Read more about the substitution of biological medicinal products.