Switch and substitution of biological medicinal products

Switching of biological medicinal products

Given the lack of information on comparisons between the different biosimilars of the same reference medicinal product, the FAMHP recommends the exclusion of biological medicinal products prescribed under an International Nonproprietary Name (INN).

The exclusion of INN prescriptions makes it impossible to switch from one biosimilar medicinal product to another without consulting the prescribing doctor. If the doctor decides to switch from one to another (i.e. original/original; original/biosimilar; biosimilar/original, or biosimilar/biosimilar), this switch must be accompanied by the necessary monitoring and the change must be specifically recorded.

However, given that a biosimilar is only approved once it has the same safety and effectiveness profile as the reference medicinal product, no change in treatment is to be expected when switching from the reference medicinal product to its biosimilar (or vice-versa).

Substitution of biological medicinal products

Substitution means switching from one speciality on medical prescription to another speciality, and is decided by the pharmacist without consultation with the prescribing doctor.

This type of substitution is not authorised in Belgium for biological medicinal products.


Last updated on 05/03/2019