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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.