SB2: An Infliximab Biosimilar

摘要

Abstract SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA and Australia. Characterization of SB2 in preclinical studies showed that it is similar to reference infliximab. SB2 demonstrated pharmacokinetic biosimilarity to reference infliximab in healthy volunteers, and clinically equivalent efficacy in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. SB2 was generally well tolerated; the safety and immunogenicity profiles were similar to those of reference infliximab with no additional safety concerns identified. Switching from reference infliximab to SB2 did not impact clinical efficacy, safety or immunogenicity. The role of reference infliximab in the management of autoimmune inflammatory conditions is well established, and SB2 provides an effective biosimilar alternative for patients requiring infliximab therapy.