US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s medicines regulator, Health Canada, in three extra indications.
Infectra was originally approved by Health Canada in January 2014 for treatment of patients with ankylosing spondylitis, psoriatic arthritis, plaque psoriasis and rheumatoid arthritis [1]. Now the approval has been extended to cover three extra indications: Crohn’s disease (CD), fistulising Crohn’s disease and ulcerative colitis (UC). Approval for CD and UC was originally not granted due to ‘differences between Inflectra and Remsima and their respective reference products’.
Biosimilars are called subsequent entry biologics (SEBs) in Canada. Inflectra is an SEB to the reference product Remicade (infliximab), and was the first monoclonal antibody SEB to be approved through the Health Canada SEB regulatory pathway.
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.
Gerry Stefanatos, General Manager, Global Established Pharma Business, Pfizer Canada said that ‘The Health Canada approval of these three additional indications for Inflectra is an important development for patients’.
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Infliximab SEB launched in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 24]. Available from: www.gabionline.net/Biosimilars/News/Infliximab-SEB-launched-in-Canada
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