• The U.S. Food and Drug Administration (FDA) recently approved Cyltezo (adalimumab-adbm), a biosimilar drug that is interchangeable with the already-approved Humira (adalimumab).
• A phase 3 clinical trial found that there are no differences in safety and efficacy between the two drugs, and Cyltezo is set to be released in the U.S. in July 2023.
• Biosimilar drugs may be offered at lower prices, reducing health care costs and increasing access to medication.

The FDA has approved Cyltezo, a biosimilar drug that’s interchangeable with Humira, for treating plaque psoriasis, psoriatic arthritis (PsA), and other conditions. Biosimilars such as Cyltezo are designed to function the same as FDA-approved biologic drugs and undergo the same rigorous testing. Doctors and researchers hope biosimilars can lower health care costs and increase access to medication for people living with chronic conditions.

Approved in October and set for release on July 1, 2023, Cyltezo is also used for treating rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, and Crohn’s disease. “As the first interchangeable biosimilar of Humira, Cyltezo represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products,” said Dr. Martin Alan Menter, chairman of the division of dermatology at Baylor University Medical Center, in a press release from Cyltezo’s manufacturer Boehringer Ingelheim.

Humira is the world’s top-selling drug. The price of the drug has steadily increased since its approval in 2002. Research from GoodRX from 2020 found that biosimilars cost 10 percent to 37 percent less than biologics, whereas generic medications cost 80 percent to 85 percent less.

How Interchangeable Biosimilar Drugs Are Tested

Cyltezo is the second interchangeable biosimilar treatment to be approved by the FDA. Biosimilar drugs are very close to other biologic drugs that are FDA-approved, but they may be made in a different way or have slightly different structures. Humira is a type of biologic drug referred to as a tumor necrosis factor (TNF) inhibitor.

Although biosimilar drugs are generally less expensive than their name-brand counterparts, they need to be as safe and effective as already-approved drugs. They undergo rigorous testing and clinical trials before being approved in interchangeable studies. These studies look to prove that treatment with either drug will give the same results. Cyltezo was compared to Humira in a randomized phase 3 clinical trial, known as VOLTAIRE-X, and researchers found no differences in safety, efficacy, and effects on the body.

“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 Dr. Janet Woodcock in a statement from the FDA. “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.”

Notably, Cyltezo and Humira come with the same potential side effects listed on their respective labels, including the risk of serious infections.

What the Approval of Cyltezo Means

With the FDA’s approval of Cyltezo as an interchangeable alternative, pharmacists will be able to substitute it for Humira without requiring a person’s health care provider to change the prescription. This change works similarly to the pharmacist substituting a generic drug for a brand name one.

Cyltezo may also cost less than Humira, helping improve access to the medication. “We believe that the introduction of biosimilars will improve the lives of patients, as well as contribute to the quality and economic sustainability of health care systems,” said Thomas Seck, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, in an interview with Healio.