On August 25th, the US Food and Drug Administration (FDA) approved Cyzelto adalimumab-adbm (Cyltezo, Boehringer Ingelheim) for multiple indications.
Cyltezo is a biosimilar of AbbVie’s Humira (adalimumab). This is the second FDA-approved biosimilar to Humira; adalimumab-atto (Amjevita, Amgen, Inc) was the first, approved in September 2016.
Cyltezo is a tumor necrosis factor (TNF) blocker approved for the treatment of adults with 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 plaque psoriasis.
View the product labeling and prescribing information for Cyltezo (adalimumab-adbm) here.