New Launch9 Apr 2025, 10:51 pm
Aurobindo Pharma's Subsidiary, CuraTeQ Biologics, Successfully Completes Phase 1 Study for Denosumab BP16 Biosimilar
AI Summary
CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma Ltd, has announced that its denosumab biosimilar, BP16, has successfully met the primary endpoints in a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) study. The study enrolled 204 healthy volunteers and compared BP16 with the reference products, Prolia®, obtained from both the EU and US markets. BP16 exhibited a PK profile nearly identical to the reference products and demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The company aims to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year.
Key Highlights
- CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, successfully completes Phase 1 study for Denosumab BP16 biosimilar.
- BP16 exhibits a PK profile nearly identical to the reference products, Prolia® from EU and US markets.
- BP16 demonstrates comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of Prolia®.
- The study enrolled 204 healthy volunteers and met all predefined endpoints.
- CuraTeQ aims to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year.