FDA Approves Biosimilar Avsola for Treating AS
This month, the U.S. Food and Drug Administration (FDA) approved Avsola for treating ankylosing spondyloarthritis (AS). Avsola (infliximab-axxq) was approved as a biosimilar to Remicade® (infliximab). Avsola is to be used for the same conditions as Remicade®. This means that Avsola can be used as a treatment option for AS!
Avsola may also reduce the symptoms of other conditions, including:
- Plaque psoriasis
- Psoriatic arthritis
- Crohn’s disease
- Ulcerative colitis
- Rheumatoid arthritis
What is a biosimilar?
Usually, medications are available in a brand name and a generic version. They contain the same ingredients and are exactly the same. But biologic medicines, like Remicade®, are made in a lab from living cells. Living cells make it hard to recreate medication exactly.
This means that instead of being generic, biologics can be “biosimilar” to one another. It's a fancy way of saying that they are made as close to identical as possible. It also means that they'll work exactly the same in your body as a biologic would.
Is Avsola the same as Remicade®?
For all intents and purposes, yes. The FDA tested how Avsola and Remicade® are broken down in the body. The FDA also tested how Avsola worked on people's symptoms. The FDA determined that both medications work in the same way, and approved Avsola to be used in place of Remicade®.
How does Avsola work?
Avsola is a tumor necrosis factor-alpha (TNF-alpha) inhibitor. TNF-alpha is a protein in the body that plays a role in the inflammatory response. In people with AS, chronic inflammation in the spine can lead to pain and stiffness. By blocking TNF-alpha with an inhibitor like Avsola (or Remicade®), the signs and symptoms of AS may be reduced. Avsola is given via an intravenous (IV) infusion every few weeks. Your doctor will help determine what dosing schedule is right for you.
What are the side effects of Avsola?
The most common side effects of Avsola include, but are not limited to, upper respiratory infections, sinus infections, sore throat, headache, abdominal pain, and infusion site reactions. Avsola is made by Amgen Inc., and Remicade® is made by Janssen Biotech, Inc.1,2
Things to know about Avsola
Avsola may increase the risk of serious infections, including tuberculosis or widespread bacterial or fungal infections. Since it impacts the immune system, Avsola may also increase the risk of developing certain cancers, such as lymphoma or cervical cancer. These are the same risks that come with Remicade® as well. In rare cases, Avsola may impact the liver, heart, or blood cells. Your doctor can help you decide if the benefits Avsola outweigh the risks.
Read the prescribing information to learn more about Avsola.
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