Boehringer Ingelheim Updates Safety Labeling of Cyltezo


The label now includes new data from the trial that supported Cyltezo’s application for interchangeability with Humira.

Boehringer Ingelheim has updated the safety labeling of Cyltezo (adalimumab-adbm) with data from the trial that was used to support its application for interchangeability with Humira (adalimumab). The FDA approved Cyltezo as the first interchangeable biosimilar of AbbVie’s Humira on Oct. 15, 2021.

“All FDA-approved biosimilars to Humira have the same label as the reference product. However, an interchangeable biosimilar is a separate, additional regulatory designation on top of the high FDA standards for a biosimilar,” a company spokesperson said in an email.

Specifically, in addition to first meeting the requirements of biosimilarity, an interchangeable biosimilar must additionally demonstrate that the risk in terms of safety or diminished efficacy of switching with the reference product is not greater than staying on the reference product in any given patient. This requirement is satisfied through an additional study of multiple switches in patients.”

Boehringer Ingelheim released data in April 2021 from the VOLTAIRE-X phase 3 trial. Results showed that in patients with moderate-to-service chronic plaque psoriasis switching several times between Cyltezo and Humira resulted in no meaningful clinical differences for pharmacokinetics, efficacy, immunogenicity, and safety. The 32-week data were presented at the American Academy of Dermatology 2021 conference.

Related: FDA Approves First Interchangeable Biosimilar for Humira

Cyltezo’s label now includes additional information about immunogenicity, as well as pediatric use. Within the section on immunogenicity, the label now says:

  • “There are two assays that have been used to measure anti-adalimumab antibodies. With the ELISA, antibodies to adalimumab could be detected only when serum adalimumab concentrations were < 2 mcg/mL. The ECL assay can detect anti-adalimumab antibody titers independent of adalimumab concentrations in the serum samples.
  • Rheumatoid Arthritis and Psoriatic Arthritis: Patients in Studies RA-I, RA-II, and RA-III were tested at multiple time points for antibodies to adalimumab using the ELISA during the 6- to 12-month period.

For pediatric use, the label adds information about use in children with juvenile idiopathic arthritis and Crohn’s disease:

  • “A pediatric assessment for Cyltezo demonstrates that Cyltezo is safe and effective for pediatric patients in an indication for which Humira (adalimumab) is approved. However, Cyltezo is not approved for such indication due to marketing exclusivity for Humira (adalimumab). The safety and effectiveness of adalimumab products have not been established in pediatric patients with JIA less than 2 years of age.
  • The safety and effectiveness of adalimumab products for the treatment of moderately to severely active Crohn’s disease have been established in pediatric patients 6 years of age and older. Use of adalimumab products for this indication is supported by evidence from adequate and well-controlled studies in adults with additional data from a randomized, double-blind, 52-week clinical study of two dose concentrations of adalimumab in 192 pediatric patients. The adverse reaction profile in patients 6 years to 17 years of age was similar to adults.
  • The safety and effectiveness of adalimumab products have not been established in pediatric patients with Crohn’s disease less than 6 years of age."

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.

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.

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