Generic substitution of biological medicinal products started
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The generic substitution of biological medicinal products at pharmacies began in April 2024, when enoxaparin products used for preventing and treating venous thromboembolism began to be covered by generic substitution.
Since 2017, physicians have had an obligation to prescribe the most affordable biological medicinal product suitable for the patient’s care. The generic substitution of biological medicinal products also allows pharmacies to substitute medicines with more affordable alternatives. The aim of this generic substitution is to increase price competition and reduce medicine reimbursement costs.
In January 2025, the substitution of medicines in pharmacies was extended to all biological medicines, such as those used for treating rheumatism, psoriasis, asthma and inflammatory bowel diseases. Insulins, however, are exempt from substitution. 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 medicinal products for patients under the age of 18 will not be substituted at pharmacies.
A biological medicinal product is a product whose active substance is a biological substance. A biosimilar is a medicine that closely resembles the original biological medicinal product and has the same effectiveness and safety. It contains the same active substance as the original medicinal product.
Fimea published a new search service to support advice on 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.
In July, Fimea published a search service compiling the differences between devices for biological medicinal products to support pharmaceutical advice provided by pharmacies. The same search also contains information on differences in inhalation delivery devices.
Only key information on the medicinal products and differences between the relevant devices are included in the search service. The search feature includes all inhalation products and biological medicines for which Fimea has produced additional information on generic substitution.