Pangaea Express - Inflectra approved for Crohn’s and Ulcerative Colitis

July 4, 2016

By Marla Weingarten

Inflectra® has been approved by Health Canada for the indications of Crohn's disease (CD), fistulising Crohn's disease and ulcerative colitis (UC). Along with the previous approval for the treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, Inflectra now has all the indications first granted to the original biologic, Remicade®. “The addition of CD, fistulising CD and 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.” Pfizer provided real world data to support the extrapolation of indications.

Following the pan-Canadian Pharmaceutical Alliance (pCPA) process, Inflectra has been listed as the preferred infliximab option for the treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis in British Columbia, Alberta, Manitoba, Ontario, New Brunswick, Nova Scotia, PEI and Newfoundland. As Inflectra is listed at 56% the cost of Remicade, it is expected that provinces will soon widen the indication for Inflectra to include the newly approved indications.

Inflectra is covered in the above provinces as the preferred infliximab for patients new to the drug, as patients already approved for Remicade continue to have coverage. However the results of the Norwegian NOR-SWITCH study that is evaluating the safety and efficacy of switching from the innovator infliximab to a biosimilar infliximab in patients with rheumatoid arthritis, spondylorarthritis, psoriatic arthritis, ulcerative colitis, crohn's disease and chronic plaque psoriasis will be presented in November. The results, if positive, are expected to have a great impact on the use of Inflectra, transforming health care providers’ comfort level with switching and influencing payers’ listing decisions.

For more information, please contact Marla Weingarten, Consultant, The Pangaea Group