What Role Does Immunogenicity Play in Biosimilars?
Immunogenicity refers to the ability of a substance to provoke an immune response. Since biosimilars and their reference products are derived from biological sources, they can potentially trigger immune reactions. Immunogenicity is a major concern in the toxicological assessment of biosimilars because unwanted immune responses can lead to adverse events such as hypersensitivity reactions or reduced efficacy of the treatment.
