BRIEF—US FDA approves the Cyltezo Pen, a new autoinjector option

The US Food and Drug Administration (FDA) has approved German family-owned drug major Boehringer Ingelheim’s Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), an FDA-approved Interchangeable biosimilar to AbbVie’s Humira (adalimumab).

Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases.

The 40mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, 2023.

“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim.

“We’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1, he added.”