FDA Approves Cyltezo, the First Interchangeable Humira Biosimilar

The FDA recently approved Cyltezo (adalimumab-adbm), the first interchangeable biosimilar to Humira (adalimumab). Cyltezo is expected to be less expensive than Humira. This is big news, since Humira is one of the most expensive popular brand-name medications in the U.S. 

There are only two FDA-approved interchangeable biosimilar products: Cyltezo and Semglee (insulin glargine-yfgn). Interchangeable products are different from other biosimilars. This is because they can be more easily substituted at the pharmacy counter.

Here, we’ll cover what you should know about Cyltezo and when it’s expected to be available.

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What is Cyltezo?

Cyltezo (adalimumab-adbm) is an injectable medication that’s given under the skin. You may be able to give yourself the shot. But a healthcare professional needs to watch you do it the first time to ensure it’s done correctly.

Cyltezo is FDA-approved to treat several different autoimmune conditions in adults. These conditions include:

• Active psoriatic arthritis

• Active ankylosing spondylitis

• Moderately to severely active rheumatoid arthritis (RA)

• Moderately to severely active Crohn’s disease

• Moderately to severely active ulcerative colitis (UC)

• Moderate to severe chronic plaque psoriasis

It’s also approved to treat a few conditions in children. These include Crohn’s disease (ages 6 and up) and moderately to severely active juvenile idiopathic arthritis (ages 2 and up).

Cyltezo is a biologic medication. Biologics are medications made from living organisms. This makes them more complex and difficult to make compared to conventional medications. That’s why they aren’t available as generics. Instead, biologics that are highly similar to brand-name biologics are called biosimilars. 

Cyltezo was originally approved as a biosimilar to Humira (adalimumab) in 2017. It’s now interchangeable with Humira. This means your pharmacist can more easily substitute it for Humira. Depending on state law, they may be able to do this without contacting your healthcare provider first.

How does Cyltezo work?

Cyltezo is a monoclonal antibody used to treat autoimmune conditions. Monoclonal antibodies are lab-made proteins that target specific substances in your body. Autoimmune conditions happen when your immune system starts attacking your own tissues. 

Cyltezo works by suppressing your immune system. It does this by targeting and blocking the effects of a protein involved in inflammation. People with certain autoimmune conditions tend to have higher levels of this protein in their joints. This can cause pain and swelling. Blocking its effects can help relieve these symptoms.

How is Cyltezo dosed?

Cyltezo dosing depends on the condition being treated. But for most conditions, it’s usually administered once every other week. It’ll be available as pre-filled syringes that contain 20 mg or 40 mg.

The typical dosing for rheumatoid arthritis (RA), psoriatic arthritis, and ankylosing spondylitis is 40 mg injected every other week. But some people with RA may need to take it more often (weekly) or at a higher dose (80 mg every other week).

Dosing for children with juvenile idiopathic arthritis is based on their weight. This ranges from 20 mg to 40 mg every other week.

Adults with Crohn’s disease, ulcerative colitis, and plaque psoriasis starting Cyltezo usually begin with a loading dose: A loading dose is when you take higher doses for a period of time to build up medication levels in your body. After the loading dose period, you’ll take 40 mg every other week.

Dosing for children with Crohn’s disease also includes a loading dose. This is followed by 20 mg to 40 mg every other week, depending on their weight.

What are the potential side effects of Cyltezo?

As with all medications, Cyltezo can cause some side effects. Most commonly, it can cause injection site reactions (e.g., pain and redness), headache, and rash.

As mentioned above, Cyltezo treats autoimmune conditions by suppressing your immune system. This can put you at higher risk of infection. For this reason, you shouldn’t start the medication until after you’ve recovered if you’re sick.

Common infections include upper respiratory tract infections and sinus infections. But it’s also possible to develop serious infections that lead to hospitalization or death.

In fact, Cyltezo has a boxed warning — the FDA’s strongest warning — about serious infections. This includes tuberculosis and other serious fungal, bacterial, or viral infections. You may be at higher risk if you’re taking it with other medications that suppress your immune system. 

Cyltezo also has a boxed warning about cancer risk in children, adolescents, and adults. This includes certain types of skin cancer, lymphoma, and leukemia. This risk may also be higher if you’re taking it with other medications that suppress your immune system.

This list doesn’t include all of the risks associated with Cyltezo. Talk to your healthcare provider about potential side effects and risks of treatment.

Can Cyltezo interact with other medications?

Yes, Cyltezo can potentially interact with other medications. For example, you shouldn’t take Cyltezo with other biologic medications used for autoimmune conditions. This can raise your infection risk. Examples of these medications include Orencia (abatacept), Kineret (anakinra), and Rituxan (rituximab).

It’s also possible that live vaccines may not work as well while you’re taking Cyltezo. They could potentially cause an infection, too. So, this combination should be avoided. Examples of live vaccines include the measles, mumps, and rubella (MMR), and chickenpox vaccines.

Cyltezo can affect proteins in your liver that break down certain medications. This may affect other medications you’re taking when starting or stopping Cyltezo. Your healthcare provider will monitor your medications and adjust your dose as needed. 

How does Cyltezo compare to Humira?

Cyltezo is a biosimilar to Humira. That means there aren’t clinically meaningful differences between the two medications. In other words, they both have the same route of administration, strength, and dosage form. You can also expect the same potential benefits and side effects.

There are five other FDA-approved Humira biosimilars. Cyltezo is the first to be considered interchangeable. Interchangeable biosimilars need to meet additional requirements for approval. This includes showing that you can switch back and forth between products without issues. So, you can use either medication and expect the same clinical result.

But Humira is available in more strengths, concentrations, and dosage forms. Cyltezo will be available only in two strengths and one dosage form (a pre-filled syringe).

Another difference between the two medications will likely be the cost. We’ll discuss that shortly.

When will Cyltezo be available?

Just like the other Humira biosimilars, Cyltezo has yet to launch in the U.S. due to patent protection on Humira. However, this will change in 2023.

As the result of a settlement agreement in 2019 with AbbVie (Humira’s manufacturer), Cyltezo is expected to be available in the U.S. starting July 1, 2023. It’s positioned to be the third Humira biosimilar to launch in 2023, following Amjevity (in January) and Hadlima (in June).

How much money can I save with Cyltezo compared to Humira?

Today, the most common version of Humira has an average retail price of over $9,000 per month. And some insurance plans have put requirements in place before they’ll cover it. Even then, Humira tends to be on a higher-tier formulary. This means you’ll likely pay more out of pocket for it.

Since Cyltezo won’t be available in the U.S. until 2023, we don’t know an exact price yet. But in general, biosimilar products tend to be less expensive than their brand counterparts. 

And over the course of 2023, at least five other Humira biosimilars will be available, too. This means there will be more competition, which can help drive down costs.

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Written by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Christina Aungst, PharmD

Christina Aungst, PharmD, is a pharmacy editor for GoodRx. She began writing for GoodRx Health in 2019, transitioning from freelance writer to editor in 2021.

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