South Korean biotechnology company Celltrion presented results of its extended trials for its biosimilar infliximab candidate Remsima (CT-P13) at the European League Against Rheumatism (EULAR) 2013 Conference, which was held in Madrid, Spain on 12–15 June 2013.
Celltrion presented results during a poster session and oral presentation showing that Remsima demonstrated clinical comparability to the originator reference product – Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab). Clinical comparability between the two drugs was demonstrated at week 14, week 30 and week 54 in all categories, including efficacy and safety profiles. No clinical differences were observed and importantly the clinical studies revealed that between patient groups using Remsima or the originator product, there was no statistically significant difference in the ratio of patients who developed anti-drug antibodies.
The extended trials were open label and were designed to study the long-term safety and efficacy of multiple doses of infliximab (5 mg/kg) administered as a 2-hour intravenous infusion per dose. The phase I trial enrolled 174 patients with ankylosing spondylitis, while the phase III trial enrolled 302 patients with rheumatoid arthritis.
The company already gained Korean Food and Drug Administration (KFDA) for Remsima on 23 July 2012 and has applied to EMA for approval of Remsima in the EU.
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