Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men
Puntos clave
Safety profiles of INTP23.1 show comparable results to reference denosumab products, supporting its potential use.
Pharmacokinetics and pharmacodynamics assessments reveal similar efficacy between the biosimilar and reference products.
Analysis focuses on healthy adult men, providing critical data for future clinical applications of biosimilars.
Immunogenicity results contribute valuable insights into long-term treatment safety of biosimilar INTP23.1.
Resumen
CTRI/2020/09/027619; Registered 07/09/2020.
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Comparison of pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a candidate biosimilar INTP23.1 with EU and US‑approved denosumab reference products in healthy adult men | Synapse