Market Overview

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

(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

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 thereof.

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

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