Nonclinical evaluation of HS630, a proposed biosimilar of trastuzumab emtansine: affinity, pharmacokinetics, and immunogenicity
HS630 and originator drug Kadcyla® exhibit pharmacokinetic similarity in tumor-bearing mice and cynomolgus monkeys following intravenous infusion. The comprehensive nonclinical evaluations of this study provide robust evidence for regulatory approval, in addition to addressing of key scientific and technical challenges in biosimilar development.
Authors
- Hui Jiang (ORCID: https://orcid.org/0000-0001-7683-267X)
- Jinjing Che
Institutions
- Dalian Ocean University (CN)
- Beijing Radiation Center (CN)
- Institute of Microbiology (CN)
- Institute of Pharmacology (CZ)
Publication Details
- Journal
- Frontiers in Pharmacology
- Published
- 2025-12-18
- DOI
- https://doi.org/10.3389/fphar.2025.1698727
- Primary Topic
- HER2/EGFR in Cancer Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00