Regulatory Decision Summary for Osnuvo

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

teriparatide [rDNA origin]

Therapeutic area:

Bone Formation Agent

Type of submission:

New Drug Submission

Control number:

215409
What was the purpose of this submission?

 

This New Drug Submission was filed to seek market authorization for a proposed biosimilar, Osnuvo (teriparatide [rDNA origin], 250 µg/mL solution for injection), for all indications currently held by the Canadian reference biologic drug Forteo (teriparatide, recombinant human parathyroid hormone [rhPTH][1-34], 250 µg/mL solution for injection).

 

Why was the decision issued?

 

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.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.