Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of teriparatide biosimilar with EU- and US-approved teriparatide reference products in healthy men and postmenopausal women
Authors' conclusion
The study demonstrated PK bioequivalence of teriparatide biosimilar to the EU- and US-teriparatide reference products with comparable PD, safety, and immunogenicity profiles.
Study context
- Population
- Healthy men and postmenopausal womenrandomized 1:1:1
- Participants
- 105 men
- Comparison
- Teriparatide biosimilar vs EU- and US-approved teriparatide
- Primary endpoint
- PK parameters Cmax, AUC0-t and AUC0-∞ (non-compartmental); bioequivalence if 90% CI of geometric mean ratio within 80.00%–125.00%
Methodological detailsassessor-blind, three-period, single-dose
- Assessor-blind
- Three-period
- Single-dose
Primary result
As reported in the abstract
PK bioequivalence (Cmax, AUC0-t, AUC0-∞)
- 90% CIs of geometric mean ratios (test:reference) of Cmax, AUC0-t and AUC0-∞ within 80.00%–125.00%: Pharmacokinetic (PK) equivalence of INTG-8 to EU- and US-teriparatide for all primary endpoints
Secondary outcomes
Pharmacodynamics (PD): total serum calcium (Emax, AUE0-t, Tmax)
- PD comparability demonstrated by similar serum calcium levels
Safety
Safety, tolerability and immunogenicity
- Deaths
- 0
- Serious AEs
- 0
- Generally well tolerated; no meaningful differences in safety or immunogenicity profiles
Original publication
Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of teriparatide biosimilar with EU- and US-approved teriparatide reference products in healthy men and postmenopausal women. Osteoporos Int. Published 26 October 2022. doi:10.
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