Validating Cross-reactivity to Infliximab Biosimilars
Biosimilars are biologics that are comparable to their reference product with respect to structure, efficacy, safety and quality1. Due to the inherently variable nature of the biomanufacturing process, biosimilars are not identical copies of their reference products1. One of the main concerns with developing biosimilars is the potential for unexpected immunogenicity which may alter the efficacy of the biosimilar2,3. Therefore, with the approval of biosimilars for the treatment of IBD, it is important to research and develop therapeutic drug monitoring (TDM) processes for these drugs to analyze potential differences in immunogenicity, safety, and efficacy profiles2,3,4.
1. Jahnsen (2016). Clinical experience with infliximab biosimilar Remsima (CT-P13) in inflammatory bowel disease patients. Therap Adv Gastroenterol. 2016 May; 9(3): 322-329. doi: 10.1177/1756283X16636764. PMCID: PMC4830106.
2. Brinks (2013). Immunogenicity of biosimilar monoclonal antibodies. Generics and Biosimilars Initiative Journal (GaBI Journal). 2013;2(4):188-93. DOI: 10.5639/gabij.2013.0204.052.
3. Pineda, et al (2016). Assessing the Immunogenicity of Biopharmaceuticals. BioDrugs. 2016 Jun;30(3):195-206. doi: 10.1007/s40259-016-0174-5. PMID: 27097915.
4. Schulze, et al (2016). CT-P13 (Inflectra™, Remsima™) monitoring in patients with inflammatory bowel disease. Biologicals. 2016 Sep;44(5):463-6. doi:10.1016/j.biologicals.2016.06.011. PMID: 27435444.