Regulatory Decision Summary for Amgevita

Amgevita is a biosimilar to the Canadian authorized reference product, Humira. Both contain the active pharmaceutical ingredient, adalimumab. Adalimumab (marketed as Humira since 2004) has proven to have a favourable benefit/risk balance for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohns disease (CD), pediatric Crohns disease (pCD), ulcerative colitis (UC), plaque psoriasis (PsO) and several other diseases.

This new drug submission was submitted to support the authorization of Amgevita for several indications and clinical uses currently held by Humira in Canada (RA, PsA, AS, adult CD, pediatric CD, UC, PsO). As clinical support for authorization, the sponsor provided evidence demonstrating the pharmacokinetic similarity of Amgevita and Humira in healthy volunteers. In addition, clinically meaningful differences in safety and efficacy were not detected in two randomized, controlled, clinical trials comparing Amgevita and Humira in patients with moderate to severe RA or moderate to severe PsO. The results of these studies, in combination with the results of comparative physicochemical and biological assays, provide sufficient evidence of similarity to support the authorization of Amgevita for use in treating the aforementioned diseases. As additional support for the authorization of Amgevita, in each of the noted indications, the sponsor provided scientific rationales that adequately address the principles of extrapolation as outlined in the guidance document Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. Based on an assessment of all of the relevant information provided in the submission, Amgevita is considered to have benefit/risk balances similar to those that have been established for the claimed indications for the reference product, Humira. Therefore, the benefit/risk balance for Amgevita is considered favourable for the treatment of RA, PsA, AS, adult CD, pediatric CD, UC, and PsO.