The FDA has approved the first interchangeable biosimilar for adalimumab (Humira), a TNF inhibitor commonly taken for spondyloarthritis (SpA).
Cyltezo will be the first biosimilar that can be substituted for adalimumab without needing the prescribing physician to alter the prescription (much like generic drugs). In some states, the pharmacist can make the substitution.1
In adults, Cyltezo has been approved for ankylosing spondylitis (AS), psoriatic arthritis (PsA), Crohn’s disease and ulcerative colitis, and other conditions. In children age two and up, the medication is approved for certain types of juvenile arthritis, and in children age six and up, it is approved for Crohn’s disease. The injectable biosimilar will not be commercially available in the U.S. until July 2023, however.
“It is great news that this biosimilar has been approved,” said Maureen Dubreuil, MD, a member of SAA’s Medical and Scientific Advisory Board. “What I hope will happen is that the cost will be substantially less than the originator, adalimumab, so that insurance companies make it easier for people with axial spondyloarthritis to obtain treatment.”
The biosimilar and interchangeable biosimilar approval processes were established by the FDA to increase the pool of affordable medications available to those who live with chronic diseases, according to acting FDA commissioner Janet Woodcock, MD.
To obtain interchangeable status, a medication must perform well in a study in which patients undergo multiple switches between the biosimilar and the original drug. In a phase 3 clinical trial for Cyltezo, there were no significant differences between a group that switched back and forth between the biosimilar and adalimumab, and a group that continuously received only adalimumab.2
Many rheumatologists who treat and advocate on behalf of those with SpA and related conditions are welcoming the news.
“At present, there are some insurance companies that require a trial of an oral medication such as methotrexate or sulfasalazine, which are not recommended for treatment of axial spondyloarthritis, before starting a biologic. I hope that requirements like these are abandoned as the cost of treatment is reduced with biosimilar options,” Dubreuil said. “Hopefully we’ll continue to see post-marketing studies that confirm the efficacy and safety of the biosimilar.”
1. First Interchangeable Humira Biosimilar Approved | MedPage Today
2. FDA approves Cyltezo as first interchangeable biosimilar for inflammatory disease (healio.com)