More and more biological medicinal products can soon be substituted with a cheaper alternative at a pharmacy

Since 2017, physicians have had an obligation to prescribe the most affordable biological medicinal product suitable for the patient’s care. The substitution of biological medicinal products in pharmacies has been introduced gradually, starting in April 2024, allowing the pharmacies to substitute biological medicinal products with more affordable interchangeable alternatives. 

Generic substitution will progress in stages until the beginning of 2026

The generic substitution of biological medicinal products at pharmacies began in April 2024, when enoxaparin products used for preventing and treating venous thromboembolism became the first biological medicinal products to be covered by generic substitution at pharmacies. In January 2025, generic substitution will be extended to all biological medicinal products, such as those used for treating rheumatism, psoriasis, asthma and inflammatory bowel diseases. Insulins, however, are exempt from substitution.

Generic substitution will be extended to insulins used in the treatment of diabetes in two batches. The generic substitution of insulin glargines 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 medicinal products for patients under the age of 18 will not be substituted at pharmacies. The FimeaWeb medicine search can be used to check what medicines are biological medicinal products. 

The original biological medicine and its biosimilar have equal therapeutic value

A biological medicinal product is a product whose active substance is a biological substance. A biological medicinal product is usually administered as an intravenous infusion or as a subcutaneous injection. Prescriptions for biological medicinal products are only valid for one year at a time.

The biosimilar is as safe and as effective as the original biological medicinal product. It contains the same active substance as the original medicinal product. The Finnish Medicines Agency Fimea creates a list of interchangeable biological medicinal products four times a year. 

Device advice ensures safe generic substitution

The administration device of the original biological medicinal product might operate differently from that of the biosimilar. However, the administration devices of interchangeable products 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.

More information

Substitution of biological medicines: information on generic substitution of biological medicinal products for medicinal product users and health care professionals (Fimea.fi) 

FimeaWeb (Fimea.fi)

For more information, please contact

Jukka Sallinen, Head of Section, tel. +358 29 522 3410

Pharmacy guidance: Pirjo Rosenberg, Head of Division, tel. +358 29 522 3246

Email addresses are in the format firstname.lastname@fimea.fi