Hulio (adalimumab-fkjp) is a biosimilar to Humira that is FDA approved for treating psoriatic arthritis and other conditions. However, Hulio will not be available for use in the United States until July 31, 2023, due to a patent agreement with AbbVie.
Hulio, like Humira, is a monoclonal antibody that blocks TNF-alpha (tumor necrosis factor alpha). Since Humira is made from living cells, it is impossible to exactly recreate it. This is different from drugs made from non-living components (like aspirin) that can be easily recreated and made into generics. A biosimilar is not a generic since it is not an exact replica.1,2
In order for a drug to be considered a biosimilar, it must prove in clinical trials that it has similar safety and efficacy as its reference product. Hulio is indicated for all of the same uses that Humira is, including psoriatic arthritis and rheumatoid arthritis. It is also approved for juvenile idiopathic arthritis (JIA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and plaque psoriasis. It is injected under the skin (subcutaneous injection).1,2
How does Hulio work for psoriatic arthritis?
Hulio, like Humira, blocks a chemical messenger in the body. This chemical messenger is called TNF-alpha. TNF-alpha sends signals throughout the body that play a role in inflammation. By reducing or blocking TNF-alpha and its effects, it may be possible to reduce inflammation. This may be critical in reducing symptoms or damage related to inflammation in certain conditions.1
What is the active ingredient in Hulio?
The active ingredient in Hulio is adalimumab-fkjp, the TNF-alpha blocker.
Hulio in clinical trials
In order for a biosimilar to be approved, its manufacturer must prove that it is similar to its reference product in structure, ingredients, effects, and safety. Hulio was approved as a biosimilar to Humira after the FDA reviewed results from the ARABESC phase 3 clinical trial.1,2
Ultimately, this trial found that there were no clinically meaningful differences between those taking Hulio and those taking Humira. The trial focused specifically on those with rheumatoid arthritis. Both Hulio and Humira had similar efficacies and safety profiles. This allowed the FDA to conclude that the drugs were biosimilar, and that Hulio could be used for all of the same conditions as Humira.1
What are the possible side effects of Hulio?
The most common side effects of Hulio include:1
- Infections, especially upper respiratory infections
- Injection site reactions
These are not all the possible side effects of Hulio. Patients should talk to their doctor about what to expect with treatment with Hulio.
Things to know about Hulio
As with any drug, there are some rare but serious risks to look out for when taking Hulio. Hulio has two black box warnings for serious infections and malignancy (cancer).
Because it interferes with the normal signaling of the immune system, Hulio may increase a person’s risk of developing a severe infection. These include severe fungal infections or bacterial infections like sepsis or tuberculosis (TB). These infections can be severe enough to require hospitalization or even cause death. People starting Hulio should be tested for TB before taking the drug. If a serious infection begins to develop, Hulio will need to be stopped. Signs of a serious infection include:1
- Fever, sweats, or chills
- Cough, shortness of breath, or blood in phlegm
- Muscle aches
- Diarrhea or stomach pain
- Painful, red, or warm skin sores
- Feeling very tired
- Weight loss
- Changes in urination (like burning or increase in frequency)
People who have had hepatitis B virus in the past may be at risk for viral reactivation when starting Hulio. Many people starting Hulio will need a hepatitis B test before taking the drug.1
Additional risks and warnings
The other black box warning is for certain types of cancers, especially lymphoma (a type of blood cancer) or skin cancer. Your doctor will help monitor you and your blood counts for signs of cancer. Hulio may impact your blood cell counts in general, which your doctor will monitor for as well.1
Other rare but serious risks to watch for when taking Hulio include new or worsening heart failure or nervous system problems. Tell your doctor if you notice any numbness, tingling, changes in vision, dizziness, or weakness in your arms or legs. These are all potential signs of a nervous system issue. Signs of heart failure include shortness of breath, swelling in your ankles or feet, and sudden weight gain.
Rarely, an allergic reaction can occur when taking Hulio. Signs of an allergic reaction include hives, trouble breathing, or swelling of your eyes, lips, mouth, or face. Seek medical attention immediately if you notice any of these signs or symptoms. Other rare but serious side effects include liver issues and a lupus-like syndrome, with chest pain, shortness of breath, rash on your face or arms, and joint pain. Tell your doctor if you notice any of these issues. These should go away once Hulio is stopped.1
Considerations to discuss with your doctor
Before starting Hulio, tell your doctor if you:1
- Have had cancer or currently have cancer
- Have any issues with your nervous system
- Have tested positive for or have had TB or hepatitis B in the past
- Have heart or liver problems
- Have recently had a vaccine or are scheduled for a vaccine
- Are pregnant, planning to become pregnant, or breastfeeding
- Are taking any other medications, including over the counter drugs, vitamins, or supplements
Tell your doctor about any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.
Read the prescribing information to learn more about Hulio.