Do you have rheumatoid arthritis, ankylosing spondylitis or polyarticular juvenile idiopathic arthritis or care for someone who does? We need your valuable input.
Health Canada defines biosimilars (sometimes referred to as subsequent entry biologics or SEBs) as biologic medicines that are similar to, and would enter the market after, an approved originator biologic (such as Enbrel®).
Unlike the more common small-molecule drugs, biologics generally exhibit high molecular complexity, and are sensitive to changes in manufacturing practices. Biosimilars are not identical to their originator products because their chemical characteristics cannot be precisely duplicated during the manufacturing process. Therefore, biosimilars may have unique efficacy, immunogenicity, and safety profiles that are different from their originator.
The Common Drug Review (CDR) is currently welcoming patients and their caregivers to provide input to patient organizations on the manufacturer’s submission for biosimilar etanercept for the treatment of rheumatoid arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis. The originator biologic, or reference product, is etanercept (Enbrel®).