Regulatory Decision Summary for Erelzi

Erelzi is a biosimilar biologic drug (biosimilar) to the Canadian authorized reference product, Enbrel. Both contain the active pharmaceutical ingredient, etanercept. Etanercept (marketed as Enbrel since 2000) has an established favourable benefit/risk balance for the treatment of patients with several diseases.

This new drug submission was submitted to support the authorization of Erelzi for three of the indications currently held by Enbrel (for use in Rheumatoid Arthritis, Ankylosing Spondylitis and Juvenile Idiopathic Arthritis). As clinical support for authorization, the sponsor provided evidence demonstrating the pharmacokinetic similarity of Erelzi and Enbrel in healthy male volunteers. In addition, clinically meaningful differences in safety and efficacy were not detected in a randomized, controlled, clinical trial comparing Erelzi to Enbrel in patients with moderate to severe plaque psoriasis (an indication also held by the Canadian authorized reference product, Enbrel). However, this indication is not being claimed by the biosimilar Sponsor. In combination with the results from the comparative structural and functional studies, the results of these studies provide sufficient evidence of similarity to support the authorization of Erelzi for the indications being claimed. To further support the authorization of Erelzi, for use in the treatment of the indications being claimed, the sponsor provided scientific rationales that adequately addressed the principles outlined in the guidance document: Guidance for Sponsors: Information and Submission Requirements for Biosimilar Biologic Drugs (Biosimilars). Thus, the evidence is sufficient to allow for the indications being claimed to be authorized.

Based on an assessment of the information provided in the submission, there are no clinically meaningful differences, in terms of safety and efficacy, between the two products.