Archive · 19 Sep 2025
Aurobindo Pharma Subsidiary Completes Denosumab Biosimilar Study
Imagine a medicine to help older women with weak bones.
A company tested a copy of this medicine to see if it works the same.
They did a study with hundreds of women in Europe who have weak bones.
The study showed the copy medicine works just as well as the original.
This means it can help prevent broken bones.
The company will now ask for permission to sell this medicine in places like Europe and the US, starting in 2026.
They've already talked to some important people to make sure everything goes smoothly.
CuraTeQ Biologics completed a study of its denosumab biosimilar.
The study compared the biosimilar to Prolia (denosumab).
The study involved 446 postmenopausal women with osteoporosis.
The study was conducted in Europe.
Regulatory filings are planned for key markets from January 2026.
- Who
- CuraTeQ Biologics, a subsidiary of Aurobindo Pharma.
- What
- Completed a clinical study of its denosumab biosimilar.
- When
- Study completed; regulatory filings planned from January 2026.
- Where
- The study was conducted in Europe.
- Why
- To evaluate the efficacy of the biosimilar in treating postmenopausal osteoporosis.
- Company
- CuraTeQ Biologics Pvt Ltd (Aurobindo Pharma subsidiary)
- Study Focus
- Denosumab biosimilar
- Reference Product
- Prolia (denosumab)
- Participants
- 446 postmenopausal women with osteoporosis
- Location
- Europe (40 sites in 5 countries)
- Clinical Endpoint
- Met all endpoints, showing no significant differences
- Regulatory Filings
- Planned for EU, US, and other markets from Jan 2026