Peer-reviewedPublic domainClinical Pharmacology and Therapeutics
Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis and Pathway Evaluation
- 1Therapeutic Biologics Program, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA
- 2Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA
- 3Division of Cardiometabolic and Endocrine Pharmacology, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research U.S. Food and Drug Administration Silver Spring Maryland USA
Abstract
Biosimilar development for therapeutic proteins (TPs) with limited systemic exposure presents distinct challenges, as the new paradigm based on comparative analytical assessments plus pharmacokinetic similarity without a comparative efficacy study (CES) is inapplicable. Of 19 TPs with limited systemic exposure, 15 are well-characterized, of which 12 have at least one CES-feasible indication. The remaining 3 may require alternative strategies, including pharmacodynamic (PD) biomarker approaches or optimized CES designs, underscoring the need for proactive regulatory engagement.
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BibTeX
@article{wang2026biosimilar,
title = {{Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis and Pathway Evaluation}},
author = {Ting Wang and Jenny Zheng and Po‐Hung Hsieh and Anh‐Dung Le and Yow‐Ming Wang and Qin Sun},
journal = {Clinical Pharmacology and Therapeutics},
year = {2026},
month = oct,
doi = {10.1002/cpt.70543},
url = {https://doi.org/10.1002/cpt.70543},
note = {Public domain},
}
RIS
TY - JOUR
TI - Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis and Pathway Evaluation
AU - Ting Wang
AU - Jenny Zheng
AU - Po‐Hung Hsieh
AU - Anh‐Dung Le
AU - Yow‐Ming Wang
AU - Qin Sun
PY - 2026
DA - 2026/10/27
JO - Clinical Pharmacology and Therapeutics
DO - 10.1002/cpt.70543
UR - https://doi.org/10.1002/cpt.70543
AB - Biosimilar development for therapeutic proteins (TPs) with limited systemic exposure presents distinct challenges, as the new paradigm based on comparative analytical assessments plus pharmacokinetic similarity without a comparative efficacy study (CES) is inapplicable. Of 19 TPs with limited systemic exposure, 15 are well-characterized, of which 12 have at least one CES-feasible indication. The remaining 3 may require alternative strategies, including pharmacodynamic (PD) biomarker approaches or optimized CES designs, underscoring the need for proactive regulatory engagement.
SN - 0009-9236
SN - 1532-6535
ER -