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

Steve Fenwick; Vidhi Parekh; Naman Shah; Ronak Patel; Prashant Kale; Shrikrishna Kolte

doi:10.1007/s00210-025-04964-5

January 28, 2026Naunyn-Schmiedeberg s Archives of PharmacologyOpen Access

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

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Key Points

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.

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Implication

Observational analysis compares pharmacokinetics, pharmacodynamics, and safety of biosimilar INTP23.1 with denosumab in healthy adult men, indicating its viability as a treatment option.

Abstract

CTRI/2020/09/027619; Registered 07/09/2020.

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Fenwick et al. (2026) studied this question.

synapsesocial.com/papers/69a75b91c6e9836116a23149 https://doi.org/10.1007/s00210-025-04964-5

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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

Key Points

No abstract yet

Implication

Abstract

Discussion

Cite This Study

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

Key Points

No abstract yet

Implication

Abstract

Discussion

Cite This Study

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