FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira

U.S. Food and Drug Administration

WASHINGTON, D.C. — The U.S. Food and Drug Administration 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 (may be substituted for),  its reference product Humira (adalimumab) for Cyltezo’s approved uses. Cyltezo is the second interchangeable biosimilar product approved by the agency and the first interchangeable monoclonal antibody. Once on the market, approved biosimilar and interchangeable biosimilar products can play a role in facilitating access to treatments for many serious health conditions.

“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, M.D. “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.”

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.
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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.

Biological products, generally derived from a living organism, include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). Patients can expect the same safety and effectiveness from the biosimilar as they can from the reference product. Interchangeable biosimilar products can be expected to produce the same clinical result as the reference product in any given patient and, for biological products administered more than once to an individual, the risk in terms of safety or diminished efficacy of switching between the two products is not greater than the risk of using the reference product without such switching.

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An interchangeable biosimilar product may be substituted for the reference product without the prescriber having to change the prescription. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.

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 most serious known side effects with Cyltezo are infections and malignancies (cancers). The most common expected adverse reactions are upper respiratory and sinus infections, injection site reactions, headache and rash.

Like Humira, the labeling for Cyltezo contains a boxed warning to alert health care professionals and patients about an increased risk of serious infections that may lead to hospitalization or death. The boxed warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including adalimumab products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

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The FDA granted approval of Cyltezo to Boehringer Ingelheim on October 15, 2021.

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