Information for health care professionals

Biosimilars are biological medicines. They are equally effective and safe as the original biological medicines. The original biological medicine and its biosimilar contain the same active substance, but a different version of it, and are therapeutically equivalent. 

The dosage, potential adverse effects and precautions of the original biological medicine also apply to its biosimilar.

When applying for a marketing authorisation for a biosimilar, it has to be demonstrated that any differences between the biosimilar and its reference product do not affect the efficacy or safety of the biosimilar. Biosimilars have been on the EU market since 2006 and none have had to be withdrawn due to problems with their efficacy or safety.

For more information on biological medicines, see the Pharmaceutical safety and information section on Fimea's website.

Tell the patient that the biosimilar is as effective and as safe as the original biological medicine for treating the disease. Also tell the patient that the administration device of the original biological medicine might operate differently from that of the biosimilar. If the device is not used properly, the medicine dose may be incorrect or the administration device may become damaged.

Pharmacies are under a separate obligation to provide advice on medicines and administration devices. Although pharmacies provide guidance in the use of administration devices, it is important to remind the patient during the appointment that they have to be certain that they know how to use the delivery device correctly.

The substitution of biological medicines increases price competition and reduces the state's medicine reimbursement costs. 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.

Biological medicines are more complex in structure than conventional chemical medicinal products. Their manufacturing methods are both 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. The development of a biosimilar is therefore faster and cheaper and consequently, the price is usually lower. 

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

The schedule for substitution of biological medicines in pharmacies:

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

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

A list of original biological medicines and their biosimilars is available at FimeaWeb.

The need for substitution will be checked at a pharmacy every six (6) months. 

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

Biological medicines for patients under the age of 18 will not be substituted at a pharmacy.

With the amendment that entered into force at the beginning of 2023, the prescriptions for biological medicines will be valid for one year. On 29 September 2023, the Finnish Institute for Health and Welfare and Fimea sent instructions to physicians and pharmacies to ensure the continuation of pharmacotherapy.

Physicians have been advised to renew the requested prescriptions even if they appear to be valid for two years. Renewal of prescriptions is also recommended in connection with reception visits, even if no renewal request has been made and the validity period of one year is about to expire. 

Pharmacies have been instructed to check the actual period of validity of biological medicines and to send a renewal request for prescriptions when the one-year period under the Regulation is about to expire.

Read more:

THL: The validity periods of prescriptions will change: Prescriptions for biological medicines will be valid for one year (15 November 2023, in Finnish)

The prescriber may prohibit the on medical or therapeutic grounds. If the prescriber prohibits substitution, the reasons for the prohibition must be explained to the patient and the prohibition must be entered in the prescription. In this case, the reimbursement will be calculated from the price of the medicinal product delivered.   

The patient may prohibit the substitution of the medicine at a pharmacy if they so wish. However, if a prescription medicine is more expensive than the interchangeable medicine, reimbursement will be paid according to the reference price of the cheaper medicine. In other words, if the patient wants to continue using the more expensive medicine in the prescription, they will have to pay the difference between the price of the medicines themselves.

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.

A list of original biological medicines and their biosimilars is available at FimeaWeb. Fimea confirms the list of interchangeable medicines four times a year.