FDA Approves the Cyltezo Pen, an Autoinjector Option for Adalimumab

On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. Initially approved in August 2017 as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases including rheumatoid arthritis, juvenile idiopathic arthritis, Crohn’s disease, and plaque psoriasis. The 40 mg/0.8 mL pre-filled Cyltezo Pen will be available in two-, four- and six-pack options on July 1, 2023. The Cyltezo Pen features a one-button, three-step activation, with 100% drug visibility and a protected needle.

According to Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim: “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.”