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Guidance Documents Biologics Cancer

Bispecific Antibodies: US FDA May Require Comparison To Approved Monospecific Product

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Executive Summary

When approved therapies target the same antigens as the investigational bispecific antibody, FDA may request a comparative clinical trial, draft guidance notes.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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