FDA Nod for Cyltezo Autoinjector Pen

Cyltezo is an FDA-approved interchangeable biosimilar to Humira (adalimumab). 

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm).

Cyltezo is an FDA-approved interchangeable biosimilar to Humira (adalimumab). 

Initially approved as a pre-filled syringe, Cyltezo is indicated to treat multiple chronic inflammatory diseases. 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 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," says Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, in a news release. "We're excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo's launch on July 1."

The patient-centered design of the pen features a one-button, three-step activation, with 100% drug visibility and a protected needle. The Arthritis Foundation has certified the Cyltezo Pen as an "Ease of Use" product.