Regulatory Decision Summary for Amgevita

Amgevita (ABP501) is a human immunoglobulin G1 (IgG1) monoclonal antibody that specifically binds and blocks TNFα, a cytokine which mediates the inflammatory response. The findings from the original NDS review at BRDD demonstrates that Amgevita is highly similar to Humira and is expected to have similar clinical activity in all indications for which the reference product has been studied and approved.

This SNDS seeks extension of biosimilarity to the pJIA, HS, Uveitis indications that are currently authorized for Humira in Canada (Product Monograph [PM] dated July 24, 2018). These indications were not studied in ABP501 clinical program. The sponsor clarified that the quality assessment of similarity for Amgevita (ABP501) remains unchanged. No elements of the totality of evidence assessment, including analytical, functional, non-clinical or clinical studies, have been changed, therefore, the original biosimilarity status for Amgevita remains valid. The Health Canada Guidance Document on Information and Submission Requirements for Biosimilar Biologic Drugs (dated 2016/11/14) stated that where similarity has been established, indications may be granted even if clinical studies are not conducted in each indication. To support extension to the non-studied indications sought by this SNDS, the sponsor provided a scientific rationale to justify that ABP 501 and Humira would be expected to have similar effect with respect to the MOA and the known effect of adalimumab affecting safety, immunogenicity, and efficacy in each of the indications sought.

Overall, the extension to non-studied indications of pJIA, HS, and Uveitis sought by this Amgevita SNDS is considered appropriate, given the validity of biosimilar status of Amgevita to Humira (at the time of this SNDS review), the known scientific rationales for adalimumab in each of the sought indications, and in accordance with the Health Canada Guidance Document for Biosimilar Biologic Drugs. The benefit/risk ratio for Amgevita is expected to be similar to Humira for which the indications that have been authorized.