The FDA approved the supplemental Biologics License Application (sBLA) for Boehringer Ingelheim's Cyltezo (adalimumab-adbm) as the first Interchangeable biosimilar with Humira (adalimumab). The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases and this latest approval designates it as Interchangeable across all of these indications.

“We are proud to be the company driving the advancement of biosimilars and delivering the first and only Interchangeable biosimilar with Humira®. It is a true milestone and an important step forward for broader adoption in the US and for patient access to affordable medicines,” says Thomas Seck, senior vice president, Medicine and Regulatory Affairs at Boehringer Ingelheim, in a news release. “The Interchangeability status of Cyltezo® reinforces our goal of expanding overall treatment options and contributing to the quality and sustainability of the U.S. healthcare system.”

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, in order to achieve the interchangeable designation, the FDA requires an additional clinical study of multiple substitutions in patients, known as an Interchangeability study. This type of study shows how patients do when they are switched back and forth multiple times from a reference product to the Interchangeable biosimilar candidate. A biosimilar with an Interchangeable designation can be auto-substituted by a pharmacist for the reference product, with individual state laws controlling how and whether physicians will be notified.

“As the first Interchangeable biosimilar of Humira, Cyltezo (adalimumab-adbm), represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products,” says Martin Alan Menter, MD, chairman of the Division of Dermatology at Baylor University Medical Center. “This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo® has the same efficacy and safety as the originator medicine with the added benefit of cost savings.”

The approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s Phase 3 randomized VOLTAIRE-X clinical trial and marks the first FDA approval for such a study. The VOLTAIRE-X trial studied the effects of multiple switches between Humira and Cyltezo. This additional study demonstrated that Cyltezo is equivalent to Humira with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups. The results were presented at the American Academy of Dermatology 2021 conference.

Cyltezo is not commercially available in the US at this time, but its commercial license will begin on July 1, 2023.