Biosimilar Monoclonal Antibodies: Considerations for Gastroenterologists

Natali Serra-Bonett, AbbVie Farmacéuticos, SA de CV, Mexico City, Mexico
Freddy Faccin, AbbVie Inc., Biotherapeutics, Global Medical Affairs, San Juan, PR, USA

Background and primary objective: The first biosimilar of the tumor necrosis factor-alpha inhibitor infliximab has been approved in multiple countries. Indication extrapolation was a key area in which regulatory decisions differed. This review provides an overview of biosimilarity, and discusses approaches to indication extrapolation, issues relating to immunogenicity, and clinical implications for gastroenterologists.
Procedures: This was a narrative review of regulatory guidelines related to biosimilar products with a focus on indication extrapolation, immunogenicity, and clinical implications for gastroenterologists.
Discussion and conclusions: Biosimilarity is established with comprehensive quality comparisons followed by comparative nonclinical and clinical studies. Differences identified during the quality comparison may have clinical implications and must be investigated. Although comparative analytical data provide the foundation for use of a biosimilar for the specific indication(s) tested, additional factors must be considered when determining the appropriateness of indication extrapolation. Current abbreviated regulatory processes are facing challenges about the indication extrapolation of complex biologics such as monoclonal antibodies, particularly when there are potential differences in disease pathogenesis and safety and immunogenicity profiles between the target populations/indications. Particularly relevant to gastroenterologists is whether clinical study data in rheumatologic diseases, taken together with the analytical and preclinical data, form an adequate basis for approval of a biosimilar in inflammatory bowel disease-related indications. The results of ongoing studies of biosimilar infliximab in patients with inflammatory bowel disease are anticipated to help to better inform clinical decisions regarding this product.

Palabras clave: Biosimilars. Indication extrapolation. Inflammatory bowel disease. Infliximab. Tumor necrosis factor.