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# Boehringer’s Humira Biosimilar Now ‘Interchangeable’
- URL: https://www.fdaweb.com/boehringers-humira-biosimilar-now-interchangeable/
- Published: 2021-10-18T12:00:00.000Z
- Updated: 2026-09-14T17:19:19.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150381

FDA has approved a Boehringer Ingelheim Pharmaceuticals supplemental BLA for Cyltezo (adalimumab-adbm), an interchangeable biosimilar that will allow pharmacy substitutions without prescribers’ concurrence. Cyltezo was originally approved 8/2017 as a biosimilar version of Abbott’s Humira (adalimumab) for multiple inflammatory diseases.

“Interchangeable biosimilar products can be expected to produce the same clinical result as the reference product in any given patient and, for biological products administered more than once to an individual, the risk in terms of safety or diminished efficacy of switching between the two products is not greater than the risk of using the reference product without such switching,” an FDA [news release](https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira?ref=fdaweb.com) says.

Like Humira, Cyltezo’s labeling contains a boxed warning about an increased risk of serious infections that may lead to hospitalization or death. “The boxed warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products,” the agency says.. “The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.”