Regulatory Decision Summary for Hyrimoz

Hyrimoz (adalimumab) is a biosimilar to the reference biologic drug, Humira (adalimumab). Currently, Hyrimoz is authorized for the following indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, adult hidradenitis suppurativa, plaque psoriasis, and adult uveitis.

This SNDS seeks authorization of Hyrimoz for the pediatric uveitis, pediatric Crohn’s disease, and adolescent hidradenitis indications held by the reference biologic drug, Humira. Although the indications sought in this submission have not been studied in the Hyrimoz 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 Hyrimoz to Humira was previously established in New Drug Submission Control No. 217314 based on comparative structural, functional, non-clinical, and clinical studies. To further support the use of Hyrimoz 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. In particular, it was noted that the treatment effect of adalimumab in all indications is based on the same mechanism of action (i.e., binding to TNF-alpha and blocking its interaction with the p55 and p75 cell surface receptors) and the underlying pathogenic processes of Crohn’s disease, uveitis, and hidradenitis suppurativa are similar between pediatric and adult patients. As such, Hyrimoz and Humira would be expected to have similar efficacy, safety, and immunogenicity profiles in the proposed pediatric indications that have been authorized for Humira.

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 Hyrimoz in pediatric Crohn’s disease, adolescent hidradenitis, and pediatric uveitis are considered to be similar to those established for Humira. Therefore, the benefit-risk profile for Hyrimoz is deemed favourable for the treatment of pediatric Crohn’s disease, adolescent hidradenitis, and pediatric uveitis.