European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima®

Dec. 3, 2018 02:52 UTC
  • European Medicines Agency started to officially review ‘Remsima SC’; expecting European approval in the second half of next year

INCHEON, South Korea--(BUSINESS WIRE)-- Celltrion, Inc. (KRX:068270) today announced that the European Medicines Agency (EMA) has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab. An opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) 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 (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 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.

“Celltrion is set to promote its Remsima® and Remsima SC as global blockbusters by increasing the Remsima brand share in TNF-α inhibitor market under the strategy of diversifying products with existing IV formulation of Remsima®, already sharing 52% of the Europe’s original medicine market.” says an official from Celltrion. “In addition to these efforts, we will lead the TNF- α inhibitor market with upcoming commercialization of the SC formulation of ‘CT-P17’ as a high-concentration formulation of a proposed adalimumab biosimilar referencing AbbVie’s Humira®, which is undergoing clinical trials.”

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing 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. For more information, visit www.celltrion.com.

 

Contacts

Celltrion, Inc.
IR Contacts:
Josh Hwang, +82 32 850 5171 / Josh.hwang@celltrion.com
PR Contacts:
Gunn Lee, +82 32 850 5168 / Gunhyuk.lee@celltrion.com
Heewon Park, +82 32 850 5356 / Heewon.park@celltrion.com

 
 

Source: Celltrion, Inc.

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