Aurobindo Pharma’s Bone Loss Biosimilar Gets Positive Results From Phase 1 Study 

Aurobindo Pharma Ltd. on Wednesday said its wholly-owned unit CuraTeQ Biologics Pvt. Ltd. has announced positive results from a Phase 1 study of its denosumab biosimilar, BP16.

The pharmacokinetic and pharmacodynamic study enrolled 204 healthy volunteers across three groups to compare BP16 with the reference product, Prolia, sourced from the European Union and US markets, the company said in an exchange filing.

Denosumab targets the RANK ligand, a key protein in osteoclast activity. By inhibiting RANKL, the treatment is effective in managing bone loss-related conditions such as osteoporosis in postmenopausal women, bone metastases, and cancer-related bone complications, the company said.

The Phase 3 trial is underway across multiple sites in the EU, with completion expected by May and the company aims to submit a marketing authorisation application to the Committee for Medicinal Products for Human Use in the third quarter of this financial year.