A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers

BACKGROUND: P044 is a proposed biosimilar candidate of Teriparatide for reference medicine, Forsteo®. This study was designed to evaluate the Pharmacokinetic/Pharmacodynamic (PK/PD) bioequivalence between P044 and Forsteo®. METHODS: for PD parameter, additional PK parameters and safety. RESULTS: Sixty-six subjects were enrolled in the study and baseline demographics were similar between the two treatments. The two treatments presented similar PK/PD parameters and the 90% confidence interval for primary and secondary endpoints were within the bioequivalence acceptance range (80.00-125.00%) for all parameters. None of the subjects experienced serious adverse event, and all of the reported adverse events were mild and similar between two treatments. CONCLUSIONS: This study demonstrated the PK/PD similarity of P044 to reference medicine, Forsteo® and safety profiles were comparable between treatments. TRIAL REGISTRATION: EudraCT Number: 2019-004477-82.