Therapy Areas: Inflammatory Diseases
FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
19 October 2021 - - The US Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases, the agency said.

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.

Cyltezo is approved for indications in adult patients including 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.

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.

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.

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

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

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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