Regulatory Decision Summary for Inflectra
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this Supplemental New Drug Submission (SNDS) is to seek marketing authorization for Inflectra (infliximab for injection) for the treatment of pediatric patients with Crohns disease or ulcerative colitis, and to add a dose escalation regimen up to 10 mg/kg in adult patients with rheumatoid arthritis.
Why was the decision issued?
Inflectra (infliximab for injection) is a biosimilar to the Canadian authorised reference product Remicade. Both biologics contain the active pharmaceutical ingredient infliximab. Infliximab has previously been demonstrated to have a favourable benefit-risk profile for the treatment of adults with rheumatoid arthritis (RA), ankylosing spondylitis, Crohns Disease, fistulising Crohns Disease, ulcerative colitis, psoriatic arthritis, or plaque psoriasis.
These data provided in this Supplemental New Drug Submission supports the authorization of Inflectra for the treatment of pediatric Crohns Disease and ulcerative colitis, and a dose escalation in adult patients with RA. The requested indications and changes to the Product Monograph are consistent with the reference product Remicade.
The pediatric Crohns Disease and ulcerative colitis indications, and the dose escalation for adult patients with rheumatoid arthritis that are included in the revised Inflectra PM are based on continuing biosimilarity to Remicade and the favourable benefit-risk profile of the reference product Remicade.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.