Immunogenicity of biosimilars
- Drugs & Therapy Perspectives
Authors: Sanja Mirkov, Russell Hill
Publisher: Springer International Publishing
Biologics and biosimilars are biotechnology-derived proteins and have the potential to be highly immunogenic. The consequences of an immune reaction to a therapeutic protein range from transient reactions to severe life-threatening conditions. Patient-, disease- and product-related factors influence the development of immunogenicity, and assessment of immunogenicity is always required for approval of a biosimilar. Assessment of a biologic immunogenicity profile is conducted in equivalence clinical trials to confirm that the immunogenicity profile of the biosimilar is similar to that of its reference biologic. A summary of clinical trials assessing the immunogenicity of infliximab biosimilars in patients with rheumatoid arthritis and ankylosing spondylitis and the results from observational studies in patients with gastroenterology diseases are presented. Due to the small patient populations studied in the equivalence clinical trials, the immune response may not be captured prior to licencing of the biosimilar. Therefore, ongoing pharmacovigillance is required to ensure the safe use of these novel therapies.