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    FDA modifies immunogenicity language in final bispecific antibody guidance

    A newly finalized guidance on bispecific antibodies from the US Food and Drug Administration (FDA) notes that although bispecific antibodies can generally be characterized in the same ways as standard monoclonal antibodies and manufacturing processes may be similar, some scientific and regulatory considerations are unique to bispecifics.   According to a 24 May agency announcement , while the regulatory pathway for evaluating monoclonal antibodies is “well established...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...