Policy & Regulation
European Medicines Agency Accepts Extension of Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima
6 December 2018 - - The European Medicines Agency has accepted for review of the Extension Marketing Authorisation Application for 'Remsima SC', the subcutaneous version of Remsima, the autoimmune disease therapeutic antibody biosimilar of infliximab, South Korean biopharmaceutical company Celltrion, Inc. (KRX: 068270) said.

An opinion from the EMA's Committee for Medicinal Products for Human Use on the Extension Marketing Authorisation Application for Remsima SC is expected in the second half of 2019.

In a bid to secure competitiveness in the TNF-α inhibitor (autoimmune disease therapeutic agent) market through 'twin-track' strategy together with the existing intravenous 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 for the safety, pharmacokinetic and efficacy assessment of Remsima SC.

The development of subcutaneous formulation of Remsima is one of Celltrion's marketing strategies to increase TNF-α inhibitor market share.

The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle, unlike intravenous formulation of Remsima that requires patients to visit hospitals for the administration thereof.

Celltrion expects that the potential users will include patients who are satisfied with the therapeutic effects of infliximab and yet want to be administered with the subcutaneous formulation.

Headquartered in Incheon, Korea, Celltrion is a biopharmaceutical company, specialising in research, development and manufacturing 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, respectively, which is the world's first mAb biosimilar to receive approval from a regulatory agency in a developed country.