How Boehringer In­gel­heim and Pfiz­er bat­tled over the ex­clu­siv­i­ty of the first Hu­mi­ra in­ter­change­able

Ten com­pa­nies are now com­pet­ing for mar­ket share with Ab­b­Vie’s megablock­buster rheuma­toid arthri­tis drug Hu­mi­ra (adal­i­mum­ab), but two of those com­peti­tors — Pfiz­er and Boehringer In­gel­heim — have al­so been bat­tling be­hind the scenes with the FDA over when the 18 months of ex­clu­siv­i­ty for Boehringer’s in­ter­change­able biosim­i­lar should end.

The length and ex­tent of the in­ter­nal bat­tle at the FDA be­tween Pfiz­er and Boehringer first came to light on Thurs­day with the FDA’s re­lease of a memo. It shows the ex­tent to which in­dus­try and the FDA are still fig­ur­ing out and in­ter­pret­ing the ap­proval path­ways for biosim­i­lars and in­ter­change­able biosim­i­lars, even 13 years af­ter the BP­CIA was signed in­to law.

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