FDA approves first interchangeable biosimilar for Humira

The FDA said Oct. 18 it has approved Cyltezo, the first interchangeable biosimilar for AbbVie's best-selling drug Humira. 

Cyltezo, made by Boehringer Ingelheim, is the second interchangeable biosimilar drug approved by the FDA, following the approval of Mylan's Semglee in July. It is the first interchangeable monoclonal antibody approved. 

An interchangeable biosimilar drug is one that can be subsistuted for its reference product — in Cyltezo's case, Humira — without the prescriber having to change the prescription. The substitution can occur at the pharmacy, similar to how generic drugs are substituted for brand-name drugs, subject to state pharmacy laws. 

Cyltezo can treat rheumatoid arthritis, Crohn's disease, ulcerative colitis and more. It is administered subcutaneously by a physician. 

Read the FDA's full news release here.

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