FDA Approves the First Interchangeable Biosimilar for Humira

The Food and Drug Administration recently approved Cyltezo (adalimumab-adbm), the first interchangeable biosimilar product of Humira (adalimumab).

Humira is an injectable drug widely used to manage symptoms of rheumatoid arthritis (RA) and several other autoimmune conditions.

Cyltezo is expected to be more affordable than Humira, which can cost up to $9,000 a month. However, the new product will not be available until July 2023 because Humira is protected by a patent until then.

“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” acting FDA Commissioner Janet Woodcock, MD said in a press release. “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 use in adults who have the following conditions:

• 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;
• moderate to severe chronic plaque psoriasis.

It is also approved for treating children aged 2 and above with moderate to severe active polyarticular juvenile idiopathic arthritis and for children aged 6 and above with Crohn’s disease.

While Humira is also approved for treating uveitis, an inflammatory condition of the eye, Cyltezo is not approved for this use.

Biologic drugs like Humira are often more costly because production requires living organisms. Biosimilars can recreate the molecules of their “original” brand-name drug and offer the same level of effectiveness at a lower cost.

In most states, pharmacists are allowed to swap brand-name drugs for an FDA-approved biosimilar version, says Ilisa Bernstein, PharmD, JD, senior vice president of pharmacy practice and government affairs at the American Pharmacists Association.

“An interchangeable biosimilar provides greater access and affordability for patients in need of these products,” Bernstein tells Verywell.

What to Know About Cyltezo

Cyltezo is a monoclonal antibody drug that suppresses the immune system and keeps it from attacking tissues like joints or overreacting in conditions like psoriasis. Since it suppresses the immune system, it may increase the risk of serious infections, according to the FDA. But the most common side effects are upper respiratory and sinus infections, redness around the injection site, headache, and rash.

Cyltezo will be available only by prescription. It is injected subcutaneously, just under the skin. Dosage varies, depending on the condition for which the drug is being used.

A typical dose for treating rheumatoid arthritis, for example, is usually 40 milligrams every other week. For some conditions, the first few doses of Cyltezo are larger than the following ones.

The dosages of Cyltezo for children are based on their weight.

Cheaper Alternative to Humira

In general, biosimilar drugs usually cost less than the original biologics, which can have huge price tags. Boehringer Ingelheim, the maker of Cyltezo, has not set a price for the drug yet.

Humira can cost up to $9,000 a month if people were to pay out-of-pocket, but there are discount programs and coupons available. Insurance companies will often require physicians to try other drugs and treatments before they will pay for an expensive biologic like Humira. Patients may also have to a higher co-pay than other drugs.

People who are taking a biologic can ask their pharmacists about whether there is a cheaper option. “The pharmacist has all the information and can tell them if a cheaper alternative or a less expensive different biologic could be helpful for them,” Bernstein says.