Celltrion Finalizes Clinical Trials for Remsima SC, Planning to File a Marketing Authorization Application to the EMA in H2
- Completing clinical trials for the patient convenience-enhanced ‘Remsima SC’, the subcutaneous version of Remsima®, to file a Marketing Authorization Application to the European Medicines Agency
- Diversifying products with ‘Remsima SC’ and the adalimumab Biosimilar ‘CT-P17’ as a high-concentration formulation in a strategy to boost its TNF-α inhibitor market competitiveness
INCHEON, South Korea--Celltrion (KRX:068270) today announced that the company has completed Phase 3 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.
In a bid to obtain its competitiveness in the TNF-α 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 3 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 there of.
Celltrion expects that the potential demand base will include those patients who are satisfied with the therapeutic effects of infliximab and yet who want to be administered with the subcutaneous formulation, and those patients who are administered with the Abbvie’s Humira® and Amgen’s Enbrel®, which are global blockbuster biopharmaceuticals as TNF-α inhibitor SC formulation.
About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®(CT-P13), respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.