Remsima™ is the world’s first biosimilar monoclonal antibody (mAb) medication to be approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).
Remsima™ was approved by the EMA in September 2013 and by U.S. FDA in April 2016, for treatment of patients with a number of serious autoimmune diseases, including Crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA) and plaque psoriasis (PsO).
Remsima™ is approved in 79 countries across the globe as of Jan 2017.
 As of April 5th, 2016, the U.S. Food and Drug Administration(FDA) has approved Inflectra™ (biosimilar infliximab), also known as its other brand name Remsima™ or Flammegis™, for all indications of the reference product, Remicade™. It is the first and only FDA-approved biosimilar monoclonal antibody (mAb).
 Approved indications vary among countries.
Remsima™,the world first biosimilar mAb (approved in 2013 by EMA and in 2016 by FDA)
- Indications : Rheumatoid arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Adult Crohn’s Disease, Psoriasis, Psoriatic Arthritis
- Protein type : Monoclonal antibody (mAb)
- Mechanism of action : Neutralizes tumor necrosis factor - α (TNF - α), a common cause of autoimmune diseases such as rheumatoid arthritis
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