Biosimilar Cyltezo Gets FDA Approval for Multiple Indications

This marks the second approval of a biosimilar for adalimumab.

The Food and Drug Administration (FDA) has approved Cyltezo (adalimumab-adbm; Boehringer Ingelheim) subcutaneous injection, a new biosimilar to Humira (adalimumab; AbbVie). The first Humira biosimilar, Amjevita (adalimumab-atto; Amgen), was approved by the FDA in September 2016.

Cyltezo, a recombinant tumor necrosis factor (TNF) blocker, is indicated to treat adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate-to-severe plaque psoriasis. In pediatric patients, Cyltezo is indicated to treat moderately to severely active juvenile idiopathic arthritis in children aged ≥4 years. 

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biosimilar is a biological product that is approved based on showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency from the reference product, as well as meeting other criteria specified by law.

Adalimumab products work by binding specifically to TNF-alpha and blocking its interaction with the p55 and p75 cell surface TNF receptors. They also modulate biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration.

Cyltezo will be available as 40mg/0.8mL strength pre-filled glass syringes in 2-count cartons. 

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