Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis
Status:
Recruiting
Trial end date:
2024-11-24
Target enrollment:
Participant gender:
Summary
Denosumab of Intas is biosimilar denosumab candidate under development by Intas
Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian
drug licensing authority- Drug Controller General (India) for marketing in Indian population
since 2018.As per regulatory requirement, a comparative clinical study to establish
Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude
therapeutic equivalence to obtain marketing authorization of a biosimilar investigational
product. This is a multicenter, randomized, double-blind, active controlled study in
approximately 552postmenopausal women with osteoporosis.
An extension of the study is planned after completion of the initial 1 year of treatment.
This extension is with the objective of submitting data on safety, and Immunogenicity, after
switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This
switching data is applicable only for FDA submission. Only patients who have undergone PK
assessment will be eligible for the extension phase.