FDA Designates Boehringer Ingelheim’s Cyltezo® as First Interchangeable Adalimumab Biosimilar

On October 15, Boehringer Ingelheim formally secured its long-sought adalimumab interchangeability designation from the Food and Drug Administration (FDA). This label was earned based primarily on the results of Boehringer’s VOLTAIRE-X switching studies. The VOLTAIRE-X study demonstrated that patient efficacy or safety outcomes were not affected by multiple switches between Cyltezo and Humira®.

Once launched, Cyltezo will be able to be automatically substituted at the pharmacy for the reference product Humira for all its listed indications. Individual state pharmacy laws specify whether and how prescribing physicians need to be notified of any switches made by the pharmacy.

Cyltezo is not scheduled to launch until July 1, 2023, however, based on Boehringer’s settlement with AbbVie. Cyltezo will be available as a citrate-free, low-concentration dose biosimilar.

In its press release, Boehringer Ingelheim’s Senior Vice President, Medicine and Regulatory Affairs, Thomas Seck, stated,  “We are proud to be the company driving the advancement of biosimilars and delivering the first and only nterchangeable 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.” He continued, “The interchangeability status of Cyltezo reinforces our goal of expanding overall treatment options and contributing to the quality and sustainability of the US healthcare system.”

Currently, Alvotech is the only other biosimilar adalimumab developer to publicly announce that it is seeking FDA approval as an interchangeable biosimilar.

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