Regulatory Decision Summary for Hulio
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 submission was to seek authorization of Hulio, an adalimumab biosimilar, for the indication of pediatric ulcerative colitis, held by the reference biologic drug, Humira.
Why was the decision issued?
Hulio (adalimumab) is a biosimilar to the reference biologic drug, Humira (adalimumab). At the time of this submission, Hulio was authorized for the following indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and pediatric Crohn’s disease, ulcerative colitis, adult and adolescent hidradenitis suppurativa, plaque psoriasis, and adult and pediatric uveitis.
This Supplement to a New Drug Submission (SNDS) sought authorization of Hulio for the indication of pediatric ulcerative colitis, held by the reference biologic drug, Humira. Although the indications sought in this submission have not been studied in the Hulio clinical development programme, Health Canada’s guidance document on Information and Submission Requirements for Biosimilar Biologic Drugs (Revised Date: 2016-11-14) states that where each indication.
Biosimilarity of Hulio to Humira was previously established in New Drug Submission (NDS) Control No. 229124, based on comparative structural, functional, non-clinical, and clinical studies. To further support the use of Hulio in the proposed pediatric indications, sufficient scientific rationale in line with Health Canada’s guidance document on Information and Submission Requirements for Biosimilar Biologic Drugs was provided.
Based on the totality of evidence, including the previous demonstration of biosimilarity and scientific justification for the extension of indications, the benefit-risk profile of Hulio in the treatment of pediatric ulcerative colitis is considered to be favourable, similar with that established for Humira.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.