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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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CT-P10 (Truxima™): A Rituximab Biosimilar
1Springer, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.
CT-P10 (Truxima™) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. CT-P10 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA or FL. CT-P10 demonstrated clinical efficacy equivalent to that of reference rituximab in patients with RA, and was generally well tolerated in this population as well as in patients with FL. The tolerability, immunogenicity and safety profiles of CT-P10 were similar to those of reference rituximab, and switching from reference rituximab to CT-P10 had no impact on safety or efficacy. The role of reference rituximab in the management of autoimmune conditions and cancers is well established and CT-P10 provides an effective biosimilar alternative for patients requiring rituximab therapy.
CT-P10 (Truxima™) is the first biosimilar of the reference monoclonal anti-CD20 antibody rituximab. It is approved for use in all indications for which reference rituximab is approved, including follicular lymphoma (FL), diffuse large B-cell non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis. CT-P10 has similar physicochemical and pharmacodynamic properties to those of reference rituximab, and the pharmacokinetic biosimilarity of the agents has been shown in patients with RA or FL. CT-P10 demonstrated clinical efficacy equivalent to that of reference rituximab in patients with RA, and was generally well tolerated in this population as well as in patients with FL. The tolerability, immunogenicity and safety profiles of CT-P10 were similar to those of reference rituximab, and switching from reference rituximab to CT-P10 had no impact on safety or efficacy. The role of reference rituximab in the management of autoimmune conditions and cancers is well established and CT-P10 provides an effective biosimilar alternative for patients requiring rituximab therapy.
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