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)[1].

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)[2].
Remsima™ is approved in 79 countries across the globe as of Jan 2017.

[1] 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).
[2] 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

This product information is to provide medical information and educational purpose only. Not intended for the promotion or sales of the product. Ask your doctors or healthcare professionals for the detailed information.