Boehringer Ingelheim announced the FDA approved the supplemental Biologics License Application (sBLA) for 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 U.S. and for patient access to affordable medicines," said Thomas Seck, senior vice president, Medicine and Regulatory Affairs at Boehringer Ingelheim. "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," said 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."
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