Cyltezo™- Biosimilar for Humira® (adalimumab)

​​Written by: Matt Zajac | Last reviewed: June 2022 | Last updated: June 2022

Cyltezo (adalimumab-adbm) is a drug approved to treat moderate to severe rheumatoid arthritis (RA). It also is approved to treat other autoimmune conditions.1

The conditions Cyltezo is approved to treat include:1

  • Psoriatic arthritis
  • Ankylosing spondylitis
  • Plaque psoriasis
  • Ulcerative colitis
  • Crohn's disease
  • Juvenile idiopathic arthritis

Cyltezo was the first "interchangeable biosimilar" drug for these conditions. It is biosimilar to Humira. This means that it works in a highly similar way and has essentially the same safety and effectiveness as Humira. It is also interchangeable with Humira. This means it can be substituted for Humira without changing your prescription.1-3

Cyltezo works by blocking a protein called tumor necrosis factor (TNF). This helps reduce inflammation and immune system activity in RA. Cyltezo can cause serious side effects. It has a boxed warning for infections and lymphomas. Talk to your doctor about the risks of Cyltezo and what to expect during treatment.1

What are the ingredients in Cyltezo?

The active ingredient in Cyltezo is adalimumab-adbm. It is highly similar to adalimumab, the active ingredient in Humira.1

How does Cyltezo work?

Cyltezo is a biologic drug. This type of drug is made from parts of living cells. The active ingredient in Cyltezo is a protein called an antibody. Our bodies produce antibodies for our immune system to kill germs. Drug companies make antibodies to treat certain diseases, including RA.2

The antibody in Cyltezo is adalimumab, the same antibody that is in Humira. This is why the drugs are "biosimilar." The only differences between the two drugs are slight differences in inactive ingredients.2

Adalimumab attaches to and blocks tumor necrosis factor-α (TNF-α). TNF-α is a protein involved in inflammation and immune responses. People with RA and other autoimmune conditions have higher levels of TNF-α in their joint fluid (synovial fluid). Blocking TNF-α reduces damage caused by the immune system. The benefits of Cyltezo include:1

  • Reducing signs and symptoms of RA
  • Improving physical function
  • Preventing structural damage

What are the possible side effects?

Common side effects of Cyltezo include:1

  • Injection site reactions (redness, itching, pain, or swelling)
  • Upper respiratory infections (colds and sinus problems)
  • Nausea and abdominal pain
  • Headache
  • Rash

Cyltezo also can cause more serious side effects. These include:1

  • Serious infections, including tuberculosis (TB) and other viral, fungal, or bacterial infections
  • Lymphomas and other cancers
  • Allergic reactions
  • Hepatitis B reinfection
  • Nervous system problems (such as multiple sclerosis)
  • Certain blood problems
  • New or worsening heart failure
  • Immune reactions (such as a lupus-like syndrome)
  • Liver problems
  • New or worsening psoriasis

Call your doctor right away if you develop symptoms of these conditions. Your doctor may stop treatment with Cyltezo.

Cyltezo has a boxed warning, the strictest warning from the U.S. Food and Drug Administration (FDA). It has this warning because of the risk of serious infections and cancer of the lymphatic system (lymphoma). These can lead to both hospitalization and death. Do not take Cyltezo if you have an active infection. Certain medications further increase the risk of infections and should not be taken with Cyltezo. Talk to your doctor about these warnings.1,3

These are not all the possible side effects of Cyltezo. Talk to your doctor about what to expect when taking Cyltezo. You should also call your doctor if you have any changes that concern you when taking Cyltezo.

Other things to know

Cyltezo produces the same clinical results as Humira for any person with RA. This makes it easier for people with RA to access multiple treatment options. Cyltezo was the first interchangeable biosimilar drug approved by the FDA to treat inflammatory conditions.3

Use Cyltezo as your doctor prescribes. It is usually taken by an under-the-skin (subcutaneous) injection every 2 weeks. Your doctor may prescribe it with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). You may be able to self-inject Cyltezo at home after getting proper training from your doctor.1

Your doctor may perform tests before and during treatment with Cyltezo. This includes checking you for TB.1

Before beginning treatment for RA, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs. Tell your doctor about:1

  • Symptoms of infections or current treatments for an infection
  • Recurring infections
  • History of other medical conditions, especially diabetes, hepatitis B, cancers, nervous system conditions, and heart failure
  • Active TB or close contact with someone who has TB
  • Your recent travel history and where you have lived
  • Allergies
  • Scheduled major surgery
  • Scheduled vaccinations
  • Current pregnancy or plans to become pregnant

For more information, read the full prescribing information of Cyltezo.

More on this topic