FDA may re­quire bis­pe­cif­ic an­ti­bod­ies to be com­pared with mono­spe­cif­ic prod­ucts

With about 100 bis­pe­cif­ic an­ti­bod­ies ei­ther in clin­i­cal tri­als or soon en­ter­ing, the FDA on Mon­day up­dat­ed and fi­nal­ized its guid­ance on de­vel­op­ing bis­pe­cif­ic an­ti­bod­ies, clar­i­fy­ing how it may re­quire clin­i­cal tri­als to com­pare the bis­pecifics with an ap­proved mono­spe­cif­ic prod­uct.

In the era of im­munother­a­pies, the case for bis­pecifics hinges on their abil­i­ty to im­prove on mon­o­clon­al an­ti­bod­ies and more di­rect­ly tar­get can­cer tu­mor cells, among oth­er po­ten­tial in­di­ca­tions. Com­pa­nies are al­ready see­ing some pay­off, like Am­gen’s bis­pe­cif­ic Blin­cy­to, which first won ap­proval in 2018 and brought in about $380 mil­lion last year.

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