FDA ap­proves an un­brand­ed ver­sion of megablock­buster Hu­mi­ra, but Ab­b­Vie says it won't 'cur­rent­ly' launch

Late last week, the FDA ap­proved an sBLA for un­brand­ed la­bel­ing for Ab­b­Vie’s megablock­buster Hu­mi­ra (adal­i­mum­ab), open­ing the door for a po­ten­tial new way to con­tin­ue to hold on­to the tens of bil­lions of dol­lars it pulls in every year from sales of the med­ica­tion. The push comes as the Chica­go-based com­pa­ny is now fac­ing com­pe­ti­tion from as many as nine FDA-ap­proved adal­i­mum­ab biosim­i­lars and in­ter­change­able biosim­i­lars.

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