News from the FDA/CDC

Adalimumab biosimilar Cyltezo gets interchangeability designation


 

The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.

The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.

Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.


The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.

Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.

Recommended Reading

Checkpoint inhibitor–induced rheumatic complications often arise late
MDedge Dermatology
Researchers stress importance of second COVID-19 vaccine dose for infliximab users
MDedge Dermatology
Most patients with chronic inflammatory diseases have sufficient response to COVID-19 vaccination
MDedge Dermatology
Boosting the presence of darker skin in rheumatology education
MDedge Dermatology
Tocilizumab shortage continues as pandemic wears on
MDedge Dermatology
NIH to study COVID vaccine booster in people with autoimmune disease
MDedge Dermatology
Three JAK inhibitors get boxed warnings, modified indications
MDedge Dermatology
European agency recommends two new adalimumab biosimilars
MDedge Dermatology
Acceptance of biosimilars grows but greater use may hinge on switching, interchangeability studies
MDedge Dermatology
NIAMS director reflects on her mentors, spotlights research projects underway
MDedge Dermatology