Boehringer’s Humira Biosimilar Validates Equivalence in Phase III Trial

Boehringer Ingelheim posted positive trial results for another Humira biosimilar, just a month after the FDA approved Amgen’s version, Amjevita.

Amjevita has been the subject of a patent lawsuit filed by Humira’s sponsor, AbbVie, in an attempt to hold on to its international blockbuster, which had $14 billion in sales last year. Amjevita was approved in all six of Humira’s adult indications, including arthritis, psoriasis and Crohn’s disease, but not as an interchangeable product. Amgen is asserting that its product does not infringe on AbbVie’s patents.

Based on the results of the trial, which also met all secondary endpoints, Boehringer is planning to file for approval in both the U.S. and Europe, and present the full results at an upcoming scientific meeting.