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FDA Approved Biosimilar Hadlima for AS Treatment

Inflammation is a main factor in ankylosing spondylitis (AS), and treatment that helps to reduce inflammation can help provide relief to those living with AS. The US Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd), a biosimilar to the drug Humira, for the treatment of ankylosing spondylitis.1 A biosimilar is a biologic medication that is extremely similar to a biologic medicine that is already approved, in regards to safety, effectiveness, and quality.1 What is different is that biosimilars are typically less expensive, making them more accessible to patients who need them.

What is Hadlima?

Hadlima is an anti-TNF therapy targeting proteins called tumor necrosis factor (TNF). TNF is associated with inflammatory diseases like rheumatoid arthritis and ankylosing spondylitis.1 This drug helps to reduce inflammation. The FDA approval came after the Phase 3 clinical trial comparing Hadlima to Humira in patients with rheumatoid arthritis for whom methotrexate therapy didn’t work. Participants were randomized to get either 40mg of Hadlima or Humira, injected into the skin. Efficacy, safety, and the generation of an immune response were similar between the two groups, and when the Humira group was switched to Hadlima, no adverse effects were seen.1

When can I get Hadlima?

The drug will be available in the US after June 30, 2023. In addition to ankylosis spondylitis, it is also approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis.2 This will be the third TNF-targeting biosimilar approved in the US.1

As with any medication, there can be adverse effects with Hadlima, so the medication might not be for everyone. If you’re interested in whether this might be an option for you in the future, talk with your doctor.

What is ankylosing spondylitis?

Ankylosing spondylitis (AS) is a painful form of arthritis that mainly targets the spine, but other joints can be affected, as well.3 It causes inflammation of the vertebrae and can cause significant chronic pain or discomfort. When it’s severe, it can cause new bones to form in the spine, which is called ankylosis. When this happens, the spine can fuse into a fixed position. Other joints like those in the hands, hips, shoulders, and ribs can also become inflamed.

  1. FDA Approves Humira Biosimilar Hadlima for Treatment of Ankylosing Spondylitis. Ankylosing Spondylitis News. https://ankylosingspondylitisnews.com/2019/07/29/fda-approves-humira-biosimilar-hadlima-for-treatment-of-ankylosing-spondylitis/ Published July 29, 2019. Accessed August 6, 2019.
  2. FDA Approves Hadlima. Drugs.com. https://www.drugs.com/newdrugs/fda-approves-hadlima-adalimumab-bwwd-biosimilar-humira-5022.html Published July 24, 2019. Accessed August 6, 2019.
  3. Overview of Ankylosing Spondylitis. Spondylitis Association of America. https://www.spondylitis.org/Ankylosing-Spondylitis Published 2019. Accessed August 6, 2019.

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