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10/18/2021

Boehringer Ingelheim obtains FDA OK for interchangeable Humira biosimilar

The Food and Drug Administration 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.
Sandra Levy
Senior Editor
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The Food and Drug Administration has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) as the first interchangeable biosimilar with AbbVie’s Humira (adalimumab).

Originally approved in 2017, Cyltezo was designated for the treatment of multiple chronic inflammatory diseases and this latest approval designates it as interchangeable across all of these indications.

[Read more: FDA clears interchangeable insulin biosimilar Semglee]

"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, the senior vice president of 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."

"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, 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."

[Read more: Boehringer Ingelheim gets green light for new Pradaxa indications]

Cyltezo's commercial license will begin on July 1, 2023.

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