Regulatory Decision Summary for REMSIMA
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) was to seek market authorization for the subsequent entry biologic product, Remsima (infliximab), for indications and clinical uses in adult Crohns disease, including fistulising Crohns disease and adult ulcerative colitis. The market application relied on comparisons made to demonstrate similarity to the Canadian authorized product, Remicade (infliximab).
Why was the decision issued?
Remsima is a subsequent entry biologic (SEB) to Remicade. Infliximab, marketed as Remicade, has proven to provide a positive risk-benefit to patients with inflammatory bowel diseases known as Crohns disease (CD) and ulcerative colitis (UC). This SNDS addressed prior concerns identified with respect to the physicochemical and biological aspects of biosimilarity such that the authorization of Remsima for adults with CD and UC, as authorized for Remicade and including fistulising Crohns disease, could be granted via extrapolation based on the principles discussed in the Guidance Document - Information and Submission Requirements for Subsequent Entry Biologics. Extrapolation is supported based on previously submitted clinical studies that demonstrated comparable efficacy and safety in patients with Rheumatoid Arthritis and comparable pharmacokinetics in patients with Ankylosing Spondylitis. Taken together with newly submitted physicochemical and biological data and based on rationales addressing the roles of various potential mechanisms of action and their relationships to clinical outcomes in IBD, authorization based on extrapolation can be granted for the CD and UC indications. Non-comparative observational clinical data for Remsima in patients with inflammatory bowel diseases did not identify any new or unexpected safety signals. This fact, together with an assessment of the entirety of the data in this SNDS allows Health Canada to state that the benefit/risk assessment for Remsima in Crohns disease, fistulising Crohns disease and ulcerative colitis can be considered favourable
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations