FDA Approves Hulio®, A Biosimiar To Humira®

The U.S. Food and Drug Administration (FDA) has approved Hulio®, a biosimilar to Humira®. Hulio (adalimumab-fkjp) will be the sixth Humira biosimilar approved for the treatment of many inflammatory conditions. Humira is made by AbbVie, while Hulio is a joint effort from Mylan and Fujifilm Kyowa Kirin. Like Humira, Hulio is also a TNF-alpha inhibitor.

Hulio is approved for all of the same uses as Humira, including plaque psoriasis, Crohn’s disease, and ulcerative colitis. It is also indicated for use in psoriatic arthritis, rheumatoid arthritis (and juvenile idiopathic arthritis, JIA), and ankylosing spondylitis. Hulio is given via an injection under the skin (called a subcutaneous injection).1

How does Hulio work?

Hulio is part of a class of drugs called monoclonal antibodies. It is made from living cells and has a very specific target in the body. The target of Hulio, like Humira, is TNF-alpha (tumor necrosis factor alpha). TNF-alpha is a cytokine, or chemical messenger, in the body. It plays a large role in inflammation. This is the same kind of inflammation that is central in conditions like plaque psoriasis, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and more.1

By blocking TNF-alpha and its effects, it may be possible to slow down inflammation. This may help reduce symptoms or slow down damage related to an inflammatory condition.1

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.

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 side effects of Hulio?

The most common side effects of Hulio include:2

  • Infections, especially upper respiratory infections
  • Headache
  • Rash
  • 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. The first warns about the risk of serious infections that could lead to hospitalization or death. These include serious fungal or bacterial infections like tuberculosis. People starting Hulio will need to be tested for tuberculosis before starting the drug.

The other black box warning is for malignancies (cancers). Hulio may increase a person’s risk of getting certain cancers, including lymphoma. Your doctor will monitor you and your blood work to watch for signs of cancer. Other rare but serious risks of Hulio include reactivation of latent hepatitis B virus, changes in blood cell counts, nervous system issues, heart failure, and lupus-like syndrome.2

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.

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