FDA greenlights Cyltezo, first interchangeable biosimilar with Humira

The US Food and Drug Administration approved the supplemental Biologics License Application (sBLA) for Cyltezo (adalimumab-adbm), from German family-owned pharma major Boehringer Ingelheim, as the first Interchangeable biosimilar with AbbVie’s (NYSE: ABBV) mega-blockbuster Humira (adalimumab).

The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases and this latest approval designates it as interchangeable across all of these indications.

“We are proud to be the company driving the advancement of biosimilars and delivering the first and only interchangeable biosimilar with Humira. It is a true milestone and an important step forward for broader adoption in the US and for patient access to affordable medicines,” said Thomas Seck, senior vice president, medicine and regulatory affairs at Boehringer Ingelheim. “The Interchangeability status of Cyltezo reinforces our goal of expanding overall treatment options and contributing to the quality and sustainability of the US healthcare system,” he added.