Second Biosimilar to Humira Receives FDA Approval

Cyltezo from Boehringer Ingelheim joins Amjevita from Amgen

Adalimumab-adbm (Cyltezo, Boehringer Ingelheim) has become the second FDA-approved biosimilar to U.S.-licensed Humira (AbbVie).

Cyltezo, a tumor necrosis factor (TNF) blocker administered by injection, was approved for multiple indications, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis in various patient populations. 

Adalimumab-adbm carries boxed warnings for an increased risk of serious infections, such as tuberculosis; in addition, lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers.

An earlier biosimilar to Humira, adalimumab-atto (Amjevita, Amgen, Inc.) received FDA approval in September 2016.

A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

Sources: FDA; August 25, 2017; Cyltezo Prescribing Information; August 2017.