Immunogenicity of insulin preparations: a keystone to safety assessment

A.A. Mosikian^1,2, A.Yu. Babenko¹, I.E. Makarenko²

¹Almazov National Medical Research Centre, Saint Petersburg

² LLC “Geropharm”, Saint Petersburg

Having protein nature, biological preparations can cause an immune response development (IRD) in patients. IRD risks are determined by both the drug properties and the patient’s characteristics receiving the drug. The consequences of IRD vary in severity from the antibody transient occurrence to life-threatening conditions. Insulin preparations are biological medicinal products. Despite the low IRD risk during the administration of modern biosynthetic and human insulin analogues, all the possible drug-associated risks should be taken into account. This review contains information on the population selection for clinical trials of original and biosimilar insulin preparations based on patient-associated IRD risks (immune status, age, antibodies at treatment onset). Much attention is given to drug-associated immunogenicity factors: primary insulin structure, adjuvants and excipients presence, and its administration regim en. An approach to ensuring the biosimilar preparations safety that meets the international regulatory requirements was considered (by the relevant physicochemical tests and comparative immunogenicity studies), using the example of biosimilar insulin preparations.

Keywords: insulin, biosimilar, immunogenicity, immune response, antibodies.

For citation: Mosikian A.A., Babenko A.Yu., Makarenko I.E. Immunogenicity of insulin preparations: a keystone to safety assessment. RMJ. 2019;4:32–37.