FDA approves first biosimilar to Humira

Oct. 19, 2021

The U.S. Food and Drug Administration (FDA) approved the first interchangeable biosimilar product to treat certain inflammatory diseases.

 Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with Humira (adalimumab). Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody.

Cyltezo is approved for the following indications in adult patients: moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis (an arthritis that affects the spine), moderately to severely active Crohn’s disease, moderately to severely active ulcerative colitis, and moderate to severe chronic plaque psoriasis.

Cyltezo is also indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients two years of age and older, and pediatric patients six years of age or older with Crohn’s disease.

Cyltezo, offered in a single-dose, pre-filled glass syringe (40 mg/0.8 mL, 20 mg/0.4 mL), is administered subcutaneously (under the skin) under the guidance of a physician.

The FDA granted approval of Cyltezo to Boehringer Ingelheim.

To date, the FDA has approved 31 biosimilar products, including two interchangeable products, for a variety of health conditions.

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