FDA Approves First Interchangeable Monoclonal Antibody

The US Food and Drug Administration (FDA) has approved the first interchangeable biosimilar monoclonal antibody for the treatment of various autoimmune inflammatory diseases. This is the second interchangeable and biosimilar product to be approved by the FDA.

Cyltezo (adalimumab-adbm) has been approved as a biosimilar to humira (adalimumab).

Among the patient populations for which  adalimumab-adbm is approved for use are:

• Adults with moderately to severely active rheumatoid arthritis, Crohn disease, ulcerative colitis, or chronic plaque psoriasis
• Adults with active psoriatic arthritis or ankylosing spondylitis
• Children and adolescents aged 2 years or older with moderately to severely active polyarticular juvenile idiopathic arthritis
• Children and adolescents aged 6 years or older with Crohn disease

Adalimumab-adbm is administered subcutaneously in a single dose of 40 mg/0.8 mL or 20 mg/0.4 mL under physician guidance. Upper respiratory and sinus infections, injection site reactions, headache, and rash are among the common side effects. Potential adverse effects include infections and malignancies.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” said Janet Woodcock, MD, who is the acting FDA commissioner. “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.”

—Leigh Precopio

Reference:

FDA approves Cyltezo, the first interchangeable biosimilar to Humira. News release. US Food and Drug Administration; October 18, 2021. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira