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US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch

Tuesday, May 23, 2023

Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for Cyltezo (adalimumab-adbm), 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," 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."

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. For more information about the Arthritis Foundation's "Ease of Use" certification.



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