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Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis
Ting Wang1, Jenny Zheng2, Po-Hung Hsieh3
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.
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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