Health Canada approves biosimilar infliximab for additional indications: Crohn’s Disease, Fistulising Crohn’s Disease And Ulcerative Colitis

Hospira, a Pfizer Company, announced that Inflectra (biosimilar infliximab) has been approved by Health Canada for three additional indications, Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC) .

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 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.

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.

Pfizer believes biosimilars are poised to play a key role in creating a more sustainable health care system in Canada, by helping address the evolving needs of patients, physicians, government payers and private insurers. The adoption of biosimilars has the potential to expand patient access to these important medicines and to provide additional treatment options for patients living with life-threatening and chronic diseases.

Patient Access to INFLECTRA Across Canada

Following the pan-Canadian Pharmaceutical Alliance (pCPA) process, Inflectra is now available on public formularies across Canada, for the treatment of rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis. In most provinces, Inflectra is the preferred infliximab option.

In addition, Inflectra has been listed on the large majority of private insurance formularies in Canada. Inflectra also offers a comprehensive patient assistance program.

Pfizer will now work with provincial drug programs, private payers and other stakeholders to ensure CD and UC are part of the indications approved for reimbursement.