Pharmacovigilance and biological medicinal products

As for all other medicinal products, the safety of biological and biosimilar medicinal products is subject to continuous monitoring once the marketing authorisation (MA) has been granted.

With each new MA for a medicinal product, a Risk Management Plan (RMA) is established and an appropriate pharmacovigilance system is implemented. This system allows for the continuous surveillance of the safety of the medicinal product placed on the market. The risk management plan is introduced and approved at a European level. Any additional risk reduction activities are carried out at national level.

Particular attention must be paid to immunological reactions to the use of biological and biosimilar medicinal products, because data on immunogenicity (relating to the ability of any substance to provoke a specific immune response) for the reference biological medicinal product cannot be extrapolated and applied to the biosimilar medicinal product. This is why it is important that the same analyses are used in the immunogenicity comparative trials between the biosimilar and its reference medicinal product. Biosimilars cannot be approved if an increased risk of immunogenicity has been observed.

Last updated on 05/03/2019