Regulatory Decision Summary for Osnuvo

In this New Drug Submission, the sponsor originally provided data from non-clinical studies and a comparative pharmacokinetic study in healthy premenopausal women to support market authorization for the proposed biosimilar product Osnuvo. Due to the lack of comparative data from a clinical study to rule out potential clinically meaningful differences in efficacy, safety and immunogenicity between Osnuvo and the Canadian reference biologic drug, a Notice of Deficiency (NOD) was issued. In response to the NOD, data from a comparative phase III clinical study investigating efficacy, safety and immunogenicity between Osnuvo and Forteo (Japan-sourced reference product) in patients with osteoporosis at high risk of fracture was provided.

Data from the non-clinical program demonstrated the comparability of Osnuvo with the reference biologic drug Forsteo (the EU-sourced reference biologic drug) with respect to pharmacodynamics (PD), pharmacokinetics (PK) and toxicology. Comparable human PK profiles between Osnuvo and Forsteo after a single dose s.c. administration has been demonstrated in healthy premenopausal women. Comparable efficacy (measured by a clinically relevant PD parameter), safety and immunogenicity between the two products were also established between Osnuvo and Forteo (Japan-sourced reference product) in patients with osteoporosis at high risk of fracture.

Based on the totality of evidence derived from the comparative structural, functional, non-clinical and clinical data, similarity between Osnuvo and Forteo has been demonstrated. Furthermore, in accordance with Health Canadas biosimilar guidance document, a scientific rationale was provided to support the authorization of Osnuvo in the proposed indications held by the reference product Forteo and is considered satisfactory. Taken together, the risk-benefit profile of Osnuvo is considered favourable for the treatment of patients with osteoporosis at high risk of fracture.