If approved, CT-P13, a proposed biosimilar to Remicade® (infliximab), will be the first biosimilar monoclonal antibody to be licensed in the United States

INCHEON, South Korea--(BUSINESS WIRE)--Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s Remicade® (infliximab), by a vote of 21-3. CT-P13 is the first biosimilar monoclonal antibody (mAb) medication to be considered by the FDA. Celltrion is seeking approval of CT-P13 for the treatment of a variety of serious autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis, among others.

The Committee based its recommendation on the totality of evidence presented at the Arthritis Advisory Committee meeting, comparing CT-P13 to the U.S. reference product, Remicade®, in which the Committee concluded that the data submitted by Celltrion demonstrates CT-P13 is highly similar to U.S.-licensed Remicade®, notwithstanding minor differences in clinically inactive components. Further, the Committee noted that there were no clinically meaningful differences between CT-P13 and U.S.-licensed Remicade® in terms of the safety, purity, and potency of the product in the studied indications of rheumatoid arthritis and ankylosing spondylitis. The Committee acknowledged the extensive data provided by Celltrion to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use.

Remicade® has been licensed in the U.S. for 18 years and is indicated for the treatment of:

Moderately to severely active Crohn's disease in adults and children;

Moderately to severely active ulcerative colitis in adults and children;

Moderately to severely active rheumatoid arthritis;

Active ankylosing spondylitis;

Active psoriatic arthritis; and

Chronic severe plaque psoriasis.

"Given that this would be the first biosimilar monoclonal antibody to be approved in the U.S., this Advisory Committee meeting is an essential step in increasing acceptance of these critical medicines and increasing access for every patient who needs these treatments," said HyoungKi Kim, CEO of Celltrion. "We have experienced the benefits of biosimilars outside of the U.S., including Europe, and are looking forward to advancing our development program with the FDA.

"Our CT-P13 application in the U.S. is the first in an age where biosimilar mAbs are globally recognized as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable for patients," continued Kim.

If approved by FDA, Pfizer would assume commercialization rights for the medication in the United States under the proposed brand name, Inflectra™. The FDA's decision is anticipated in April 2016.

About Infliximab

Infliximab is a treatment for many autoimmune diseases, with more than 18 years of clinical data and experience since its FDA approval in U.S. in 1998. Celltrion's CT-P13, a proposed biosimilar to Remicade®, is currently approved in 67 countries across the globe including Canada, Japan and throughout Europe. CT-P13 was licensed by the European Commission in September 2013 as Remsima®/InflectraTM for all indications of its reference product, Remicade®, including moderately to severely active adult and pediatric Crohn's disease (CD), moderately to severely active adult and pediatric ulcerative colitis (UC), moderately to severely active rheumatoid arthritis (RA), severe active ankylosing spondylitis (AS), active psoriatic arthritis (PsA), and moderate to severe plaque psoriasis (PsO).

About Celltrion

Based in Incheon, Republic of Korea, Celltrion, Inc. is a global biopharmaceutical leader with strong research and development capabilities in biosimilar monoclonal antibodies (mAbs) and novel drugs for various therapeutic areas, including oncology and autoimmune diseases. Founded in 2002, Celltrion focuses on promoting the health and welfare of patients in need of innovative biopharmaceutical products through world-class manufacturing and research facilities, developing state-of-the-art technologies, and establishing quality systems. Celltrion's research and development expertise, coupled with a passion for patient well-being, is a unique set of capabilities that allowed the Company to enter into this highly challenging space.