Celltrion to advance Remsima SC, the subcutaneou version of Remsima biosimilar for filing in Europe this year.
Celltrion, Inc. has announced that the company has completed Phase III clinical trial for �Remsima SC�, the subcutaneous (SC) version of Remsima, the autoimmune disease therapeutic antibody biosimilar of infliximab, with the preparation for filing a Marketing Authorization Application to the European Medicines Agency (EMA) now in the final stage, such as the analysis of clinical data.
Celltrion is set to complete the clinical analysis soon and to submit its application for Remsima SC to the EMA in the second half of this year. Celltrion intends to improve the competitiveness in the TNF inhibitor (autoimmune disease therapeutic agent) market through �twin-track� strategy together with the existing intravenous (IV) formulation of Remsima, Celltrion has developed Remsima SC, the SC version of infliximab. Since May 2016. Celltrion has conducted Phase 1 and Phase III clinical trials on the safety, pharmacokinetic and efficacy assessment of Remsima SC.
The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to visit hospitals for the administration of the drug.
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