Regulatory Decision Summary for Amgevita
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 Amgevita, an adalimumab biosimilar, for the indication of pediatric ulcerative colitis, held by the reference biologic drug, Humira.
The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.
Why was the decision issued?
Amgevita (adalimumab) is a biosimilar to the reference biologic drug, Humira (adalimumab). At the time of this submission, Amgevita 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 Amgevita 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 Amgevita 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 similarity has been established, indications may be granted even if clinical studies are not conducted in each indication.
Biosimilarity of Amgevita to Humira was previously established in New Drug Submission (NDS) Control No. 190433, based on comparative structural, functional, non-clinical, and clinical studies.
An updated Risk Management Plan (RMP) for Amgevita was reviewed by Health Canada and considered acceptable.
Risks have been communicated in the approved Product Monograph and will continue to be monitored post-market as outlined in the Risk Management Plan, with routine and non-routine pharmacovigilance activities.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
Based on the totality of evidence, including the previous demonstration of biosimilarity and scientific justification for the extension of indications, the benefit-risk profiles of Amgevita in the treatment of pediatric ulcerative colitis is considered to be favourable, similar with that established for Humira. A Notice of Compliance (NOC) was issued.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.