Where are the in­ter­change­able biosim­i­lars?

In June 2017, Leah Christl, for­mer biosim­i­lar lead at FDA, told a con­fer­ence in Chica­go that in­ter­change­able biosim­i­lars were like­ly com­ing to the US mar­ket with­in two years.

And al­though no in­ter­change­able biosim­i­lar has been ap­proved by FDA yet, and Christl has since moved on to Am­gen, progress on in­ter­change­able biosim­i­lars has been slow in the in­ter­ven­ing years.

Most re­cent­ly, Boehringer In­gel­heim an­nounced that it has com­plet­ed, as of last April, a switch­ing study nec­es­sary for launch­ing an in­ter­change­able biosim­i­lar for Hu­mi­ra (adal­i­mum­ab), al­though the com­pa­ny did not of­fer any fur­ther de­tails on the tim­ing of its sub­mis­sion to FDA or whether there will be an ad­vi­so­ry com­mit­tee to re­view the da­ta. Boehringer al­ready has an adal­i­mum­ab biosim­i­lar ap­proved by FDA, which it will launch in the US on 1 Ju­ly 2023.

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