The first interchangeable biosimilar product to Humira (adalimumab) was approved by the FDA in October, the agency announced. Cyltezo (adalimumab-Adam), originally approved in 2017 for multiple chronic inflammatory diseases, is the first monoclonal antibody to be granted “interchangeable” status across various indications in adults: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate-to-severe chronic plaque psoriasis. The approval was based on data from the phase III randomized VOLTAIRE-X clinical trial investigating the effects of multiple switches between Humira and Cyltezo. Data showed no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity, or safety between patients switching and those receiving continuous treatment.
