Health Canada approves Inflectra (biosimilar infliximab) for three additional indications

The addition of Crohn's disease, fistulising Crohn's disease and ulcerative colitis to the approved indications was granted on the basis of similarity between Inflectra and the reference product, Remicade.

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 10 years. 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.

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.

"The Health Canada approval of these three additional indications for Inflectra is an important development for patients. We've already reached a significant milestone having successfully completed discussions with the pCPA earlier this year, and, as a result, Inflectra is the preferred infliximab option in most provinces. We look forward to our continued work with individual provinces and private insurers to support the implementation of Inflectra reimbursement," said Gerry Stefanatos, General Manager, Global Established Pharma Business, Pfizer Canada.

"Biosimilars such as Inflectra will be a key element to sustain affordable health care, especially here in Canada. Biosimilars have the potential to offer a significantly lower cost compared to the original biologic medicines. The benefits in cost saving to health care systems could be significant," said Dr Brian Bressler, Gastroenterologist, Clinical Associate Professor of Medicine, Division of Gastroenterology, University of British Columbia.