IMMUNOGENICITY

The ability of a specific substance to induce the production of antibodies in the human body; also called immune response/reaction. The EMA (European Medicines Agency) requires companies that develop biological products, whether they are original or biosimilar, to carry out extensive immunogenicity studies prior to authorisation.

Furthermore, the marketing authorisation holder must include in its Risk Management Plan a proposal for actions intended to monitor and evaluate any possible immunogenicity and its consequences once the product has been launched on the market.