Aurobindo Pharma Limited — Updates, 09-04-2025: Press Release

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has successfully completed a Phase 1 Pharmacokinetics study of its denosumab biosimilar, BP16, which met all primary endpoints against the reference products Prolia® from both EU and US markets. The study involved 204 healthy volunteers and demonstrated that BP16 achieved key bioequivalence parameters within the established range, confirming its comparable pharmacokinetic and pharmacodynamic profiles to existing products.

Positive results from this Phase 1 study set an optimistic tone for the ongoing Phase 3 study targeting postmenopausal osteoporosis, with completion anticipated by May/June 2025. A Marketing Authorization application is planned for submission in the third quarter of the fiscal year. This advancement underscores CuraTeQ’s commitment to developing high-quality biosimilars, positioning them favorably in an increasingly competitive market aimed at improving patient outcomes in chronic and debilitating conditions.