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

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion,
(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