FDA Approves Adalimumab-adbm (Cyltezo), Interchangeable Biosimilar to Adalimumab

The US Food and Drug Administration (FDA) approved adalimumab-adbm (Cyltezo), the first interchangeable biosimilar to treat inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis.

The US Food and Drug Administration (FDA) approved adalimumab-adbm (Cyltezo), the first interchangeable biosimilar to treat inflammatory disease, to Boehringer Ingelheim on October 15, 2021. Adalimumab-adbm may be substituted for adalimumab (Humira) and is the first interchangeable monoclonal antibody and second interchangeable biosimilar to be approved by the FDA. Biosimilars may aide in access to treatments for a variety of conditions.

Adalimumab-abdm is approved to treat active psoriatic arthritis and ankylosing spondylitis, moderate-to-severe rheumatoid arthritis, moderate-to-severe chronic plaque psoriasis, moderate-to-severe Crohn’s disease, and moderate-to-severe ulcerative colitis. The drug is also indicated for moderate-to-severe polyarticular juvenile idiopathic arthritis in patients aged 2 years or older and Crohn’s disease in patients aged 6 years or older.

About Adalimumab-adbm (Cyltezo)

Adalimumab is administered via subcutaneous injection and is offered in single-dose glass syringes of either 40 mg/0.8 mL or 20 mg/0.4 mL. Side effects include upper respiratory infections, sinus infections, injection site reactions, rash, and headache. Serious adverse events are infections and malignancies (cancers). The boxed warning includes a note to physicians and patients that indicates an increased risk of serious infections and states that lymphoma and other malignancies have been reported in children and adolescent patients who were receiving tumor necrosis factor blockers, such as adalimumab.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said Acting FDA Commissioner Janet Woodcock, MD. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”

About Biosimilars

Biosimilars are biological products that have no clinically significant differences, including safety and efficacy, from an already FDA-approved biological product. Interchangeable biosimilars, such as adalimumab-adbm, are designed to produce the same result as the reference drug and patients are able to switch between the 2 without increased risks or reduced efficacy. Biosimilars generally cost less than brand-name drugs and may be substituted in the pharmacy without a physician having to change the prescription.