FDA Approves First Interchangeable Biosimilar of Humira

The FDA has approved the first interchangeable biosimilar for AbbVie’s Humira (adalimumab) for multiple chronic inflammatory disease. Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) was approved by the FDA on Friday, Oct. 15, 2021.

Boehringer Ingelheim will make Cyltezo available when its commercial license begins on July 1, 2023. This date was the result of a patent ligation with AbbVie. Boehringer Ingelheim will pay royalties to AbbVie for licensing its Humira patents once Cyltezo is available.

Regulatory approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s phase 3 randomized VOLTAIRE-X clinical trial. Data showed that switching several times between Cyltezo and Humira resulted in no meaningful clinical differences for pharmacokinetics, efficacy, immunogenicity, and safety.

To be a biosimilar to an approved reference biologic, companies must demonstrate there are no clinically meaningful differences in terms of safety, potency and purity. Cyltezo was approved by the FDA in August 2017 for the treatment of multiple chronic inflammatory diseases including rheumatoid arthritis, psoriasis and Crohn's disease.

To achieve the interchangeable designation, the FDA requires an additional clinical study of multiple substitutions in patients. A biosimilar with an Interchangeable designation can be automatically substituted by a pharmacist for the reference product.

“As the first Interchangeable biosimilar of Humira, Cyltezo represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products, Martin Alan Menter, M.D., chairman of the Division of Dermatology at Baylor University Medical Center, said in a statement.