Regulatory Decision Summary for Jubbonti

The purpose of this New Drug Submission (NDS) was to obtain market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for Jubbonti, a proposed biosimilar to Prolia (denosumab), filed by Sandoz Canada Inc. The sponsor is seeking all indications currently authorized for Prolia, based on evidence of biosimilarity. After evaluating the submitted data package, Health Canada authorized Jubbonti as a biosimilar to Prolia for all indications.

Authorization was based on the totality of the evidence presented to support biosimilarity between Jubbonti and the European Union (EU)-reference product, Prolia (denosumab). This included studies demonstrating comparative clinical pharmacology, clinical efficacy, and safety profiles.

Comparable pharmacokinetic (PK) profiles between Jubbonti, United States (US)-sourced Xgeva, and EU-sourced Xgeva were established in a comparative pharmacokinetic study. The phase 1 pharmacokinetic study demonstrated PK similarity following a single subcutaneous administration of 35 mg Jubbonti to healthy subjects.

The confirmatory clinical study was a phase 3, multicenter, randomized, double-blind trial in female subjects with postmenopausal Osteoporosis (PMO). The primary efficacy endpoint was the percent change from baseline in lumbar spine bone mineral density (LS-BMD) at Week 52. The percent change from baseline in LS-BMD at Week 52 for Jubbonti was compared to that for EU-Prolia and was found to be within a predefined equivalence margin to establish clinical comparability. There were no clinically meaningful differences in the efficacy and safety of Jubbonti to EU-Prolia. The totality of the clinical evidence, including clinical pharmacokinetic, efficacy and safety comparisons, provides support to establish clinical biosimilarity between Jubbonti and Prolia.

As a biosimilar to Prolia, Jubbonti has demonstrated a comparable benefit/risk profile for the treatment of post-menopausal osteoporosis, based on the evidence provided in this submission. Additionally, based on the scientific justification and the sponsor’s rationale, this favourable profile is extended to other indications currently authorized for the Canadian reference product in line with relevant guidelines.

An updated Risk Management Plan (RMP) for Jubbonti was reviewed by Health Canada and considered acceptable. Risks have been communicated in the approved Product Monograph and will continue to be monitored post market as outlined in the Risk Management Plan, with routine and non-routine pharmacovigilance activities.

The chemistry and manufacturing information submitted for Jubbonti has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Jubbonti and dosage strength 60 mg/mL for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Jubbonti, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.