Boehringer Ingelheim announced today that Cyltezo (adalimumab-adbm), a US Food and Drug Administration (FDA)-approved Interchangeable biosimilar to Humira (adalimumab), is now commercially available in the U.S. Cyltezo was initially approved as a biosimilar in 2017 for use in multiple chronic inflammatory diseases. Cyltezo was approved as an Interchangeable biosimilar in 2021, and is available as a prefilled syringe, or as a Cyltezo Pen autoinjector.

“Cyltezo is the first and only FDA-approved Interchangeable biosimilar to Humira® that is available to the millions of people in the U.S. living with certain chronic inflammatory diseases,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim. “Cyltezo reinforces our ultimate goal of providing a more affordable and accessible treatment option for this community, and we look forward to seeing the impact it will have across the U.S.”

A biosimilar is a biological medicine that is developed to be highly similar to an approved reference biologic, with no clinically meaningful differences in terms of safety, potency and purity. An Interchangeable biosimilar must first meet the high FDA standards of a biosimilar. Then, to achieve the Interchangeable designation, the FDA requires additional data, which may include a study of multiple substitutions in patients, known as a switching study. The study must show that patients can be switched with no increased risk in terms of safety or diminished efficacy compared with remaining on the reference product in any given patient.

“Biosimilars such as Cyltezo have the potential to increase patient access to critical biologic medicines, which may benefit people living with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis,” said Steven Taylor, President, Arthritis Foundation. “We applaud the availability of another treatment option for doctors and patients in the U.S.”

The efficacy and safety of Cyltezo are supported by a large body of data, including the Phase III randomized VOLTAIRE-X comparative clinical trial, which studied the effects of multiple switches between Humira and Cyltezo compared to continuous treatment with Humira. The results of VOLTAIRE-X were presented at the 2021 American Academy of Dermatology Annual Meeting. Pharmacokinetic equivalence was demonstrated, with highly similar efficacy and immunogenicity, and comparable safety observed in patients who received either Humira continuously or who switched between Humira and Cyltezo.

“The Crohn’s and colitis patient community welcomes adalimumab biosimilars, including Cyltezo, as new options to treat these inflammatory conditions,” said Michael Osso, President and CEO of the Crohn’s & Colitis Foundation. “We look forward to seeing how these medications may improve patient care.”

“For many people living with plaque psoriasis or psoriatic arthritis, finding effective relief from symptoms can be a daily struggle. We’re always happy to have new treatment options that may help reduce the severity of symptoms and improve the quality of life for patients living with this disease,” said Leah M. Howard, J.D., President and CEO, the National Psoriasis Foundation.