FDA Approves Adalimumab-adbm as First Interchangeable Biosimilar with Adalimumab


The approval was supported by promising phase 3 data of the VOLTAIRE-X clinical trial.

Last week, Boehringer Ingelheim announced that the US Food and Drug Administration (FDA) approved the supplemental Biologics Liscense Application for adalimumab-adbm (Cyltezo), which will become the first interchangeable biosimilar with adalimumab (Humira).

Adalumumab-adbm was originally approved by the FDA for the treatment of multiple chronic inflammatory diseases back in 2017, but the latest approval will deem it as interchangeable across all of these indications.

Approval for interchangeability was prompted by the positive data seen in the phase 3 randomized VOLTAIRE-X clinical trial, which studied the effects of multiple switches from adalimumab to adalimumab-adbm.

The study found that adalimumab-adbm was equivalent to adalimumab, with no clinically meaningful differences in pharmacokinetics, efficacy, safety, and immunogenicity recorded between the switching and continuous treatment groups.

In a statement made by Boehringer Ingelheim, Martin Menter, MD, chairman of the Division of Dermatology at Baylor University Medical Center, stated that the approval represented “an important step” towards offering more affordable treatment options for complex and expensive biologic reference products to patients in need.

“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,” Menter said.

Additionally, senior vice president of Medicine and Regulatory Affairs at Boehringer Ingelheim Thomas Seck said that the interchangeability status of the biosimilar “reinforces (the company’s) goal of expanding overall treatment options and contributing to the quality and sustainability of the US healthcare system.”

Though it is not commercially available in the US, the commercial license of adalimumab-adbm will begin on July 1, 2023.

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