Clinical Pharmacology Strategies for Bispecific Antibody Development: Learnings from FDA‐Approved Bispecific Antibodies in Oncology
KyoungSoo Lim,
Xu (Sue) Zhu,
Diansong Zhou
et al.
Abstract:Bispecific antibodies, by enabling the targeting of more than one disease‐associated antigen or engaging immune effector cells, have both advantages and challenges compared with a combination of two different biological products. As of December 2023, there are 11 U.S. Food and Drug Administration–approved BsAb products on the market. Among these, 9 have been approved for oncology indications, and 8 of these are CD3 T‐cell engagers. Clinical pharmacology strategies, including dose‐related strategies, are critic… Show more
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