Regulatory Decision Summary for Amgevita

The sponsor submitted this Supplement to NDS (SNDS) seeking to add adolescent Hidradenitis Suppurativa, pediatric uveitis indications and subcutaneous (SC) dosing modification for polyarticular juvenile idiopathic arthritis (pJIA) to the Amgevita product monograph (PM) to be in line with the current labelling for the reference biologic drug Humira (PM dated June 25, 2019).

The indications and dosing modifications sought by this SNDS have not been studied in Amgevita clinical program. In accordance to Health Canadas Guidance Document for Information and Submission Requirements for Biosimilar Biologic Drugs (dated 2016/11/14), when the similarity between the reference product and the intended biosimilar has been established, indications may be granted even if clinical studies are not conducted in each indication. In this SNDS, the sponsor clarified that the quality assessment of similarity for Amgevita remains unchanged; no elements of the totality of evidence assessment, including analytical, functional, non-clinical or clinical studies, have been changed, therefore, the original assessment of biosimilarity between Amgevita and Humira remains valid.

Overall, given the unchanged validity of biosimilar status of Amgevita to Humira, the extension to the non-studied indications of adolescent HS and pediatric uveitis sought by this Amgevita SNDS is considered appropriate, in accordance with the Health Canadas Guidance Document for Biosimilar Biologic Drugs. The benefit/risk ratio for Amgevita is expected to be similar to Humira in each of the indications that have been authorized.