14 June 2016 - Hospira today announced that Inflectra (biosimilar infliximab) has been approved by Health Canada for three additional indications, Crohn's disease, fistulising Crohn's disease and ulcerative colitis.

Inflectra is Canada's first biosimilar monoclonal antibody (mAb) therapy, and was approved by Health Canada in 2014 for the treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. The addition of Crohn's disease (CD), fistulising CD and ulceratiev colitis (UC) to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade, in product quality, mechanism of action, disease pathophysiology, safety profile, dosage regimen and on clinical experience with the reference product.

While relatively new to the Canadian market, biosimilars have been approved for use in Europe for more than ten years. As a company, Pfizer has significant experience with Inflectra, and accordingly, have accumulated real world data across indications – inclusive of CD and UC.

For more details, go to: http://www.newswire.ca/news-releases/health-canada-approves-inflectra-biosimilar-infliximab-for-three-additional-indications-crohns-disease-fistulising-crohns-disease-and-ulcerative-colitis-582999681.html