Biosimilar Development

Overview

Development of bioequivalent versions of branded biologics that built foundational CMC and regulatory competency in Chinese and Taiwanese manufacturers, with a major patent-expiry cliff now driving fresh demand. Approximately 118 biologic products are forecast to lose patent protection between 2025 and 2035, yet fewer than 10% have biosimilars in active development as of 2026. Regulatory changes lowering biosimilar development barriers are prompting generic drug companies to enter the space, driving demand for CDMO protein characterization and reverse-engineering capabilities. (Segment 6 (25:00-30:00))