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FDA Approves Celltrion’s INFLECTRA™ (biosimilar infliximab) For All Indications

Celltrion, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved INFLECTRA™ (biosimilar infliximab) for all indications of the reference product, Janssen Biotech Inc.'s Remicade® (infliximab). INFLECTRA is the first biosimilar monoclonal antibody (mAb) medication to receive approval in the U.S., and is indicated for the treatment of patients with a number of serious autoimmune diseases, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

“The FDA approval of INFLECTRA, just the second biosimilar to be approved in the U.S., is significant for the medical community as this therapy has conclusively demonstrated comparable safety and efficacy to the reference product, and will provide the medical community with an alternative, more affordable treatment option,” said Vibeke Strand, MD, Adjunct Clinical Professor, Division of Immunology/Rheumatology, Stanford University School of Medicine. “This approval will help to remove barriers for the many healthcare professionals and their patients where cost and access to treatment for these chronic autoimmune diseases has been a challenge.”

The FDA based its approval on the totality of evidence presented at the Arthritis Advisory Committee meeting on February 9, 2016, demonstrating no clinically meaningful differences between INFLECTRA and U.S.-licensed Remicade® in terms of the safety, purity, and potency of the product. Following a discussion among the Advisory Committee, the panel recommended FDA approval of INFLECTRA across all eligible indications by a vote of 21-3.

“As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines,” said HyoungKi Kim, Chief Executive Officer, Celltrion. “Our experience with biosimilars outside the U.S. suggests that INFLECTRA provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the U.S.”

INFLECTRA is currently approved in 71 countries across the globe and will be commercialized by Pfizer in the United States.


INFLECTRA (biosimilar 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. INFLECTRA is currently approved in 71 countries across the globe including Canada, Japan and throughout Europe. Biosimilar i nfliximab was licensed by the European Commission in September 2013 as Remsima® /Inflectra™ 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.


for Celltrion
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Craig Heit, 212.798.9919

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