Up­dat­ed: In­ter­change­able biosim­i­lars: FDA fi­nal­izes guid­ance

The FDA on Fri­day fi­nal­ized a long-await­ed guid­ance spelling out how biosim­i­lars can achieve an in­ter­change­able sta­tus, which means they may be sub­sti­tut­ed for the ref­er­ence bi­o­log­ic with­out a pre­scriber in­ter­ven­ing.

No in­ter­change­able biosim­i­lars have been ap­proved in the US yet, and the num­ber of com­pa­nies seek­ing ap­proval for an in­ter­change­able has re­mained at just one, with Boehringer In­gel­heim pub­licly dis­clos­ing that it’s be­gun an in­ter­change­abil­i­ty study for its adal­i­mum­ab (Hu­mi­ra) biosim­i­lar.

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