FDA approves first natalizumab biosimilar for MS treatment.
FDA approves first natalizumab biosimilar for MS treatment.
Biosimilar Tyruko Approved by FDA for Treatment of Multiple Sclerosis
Image credit: Joe Amon/The Denver Post via Getty Images
Multiple sclerosis (MS) is a chronic disease that affects the central nervous system, leading to symptoms ranging from muscle weakness to vision loss and paralysis. It commonly appears in early adulthood and is more prevalent in women than men. However, thanks to several available treatments, the disease’s progression can be slowed down, preventing severe disabilities in most cases.
In a significant development, the Food and Drug Administration (FDA) in the United States has approved a new biosimilar injection called Tyruko for the treatment of relapsing forms of MS. This approval opens the door to more cost-effective treatment options for individuals with this condition.
MS affects approximately 2.8 million people worldwide. It typically strikes between the ages of 20 and 40 and is twice as common in women. The symptoms of MS can vary from mild, such as blurred vision and tingling limbs, to more severe cases involving mobility problems, paralysis, and vision loss. However, it’s important to note that most people with the disease do not experience severe disabilities.
The exact cause of MS is still unknown, but it is believed to be an autoimmune disorder in which the body’s immune cells attack the protective myelin sheath surrounding nerve cells. Though not hereditary, there is evidence of genetic susceptibility with environmental triggers.
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Treatment options for MS focus on slowing down disease progression, which can be costly, especially when it comes to biologic medications used to treat the relapsing forms of the condition. One such medication is natalizumab (Tysabri), a monoclonal antibody that effectively reduces symptoms during flare-ups and minimizes the rate of relapses in people with relapsing-remitting MS.
Now, the FDA has approved a biosimilar version of natalizumab for individuals with MS and Crohn’s disease. This biosimilar is called Tyruko and is expected to have the same efficacy and safety as the original medication.
Tysabri works by preventing white blood cells, known as leukocytes, from reaching the central nervous system and attacking the myelin sheaths surrounding nerve cells. Tyruko functions in the same way and is highly effective in preventing relapses.
However, Tysabri does come with side effects, the most severe being an increased risk of progressive multifocal leukoencephalopathy (PML), a viral brain infection that can lead to death or severe disability. As a result, everyone using Tysabri is required to participate in the TOUCH program, a national initiative that aims to minimize the risks associated with PML and promote informed decision-making regarding natalizumab use. Tyruko will also be subject to monitoring under an FDA risk evaluation and mitigation strategy (REMS).
Dr. Barbara Giesser, a neurologist and MS specialist, explained, “Tyruko is a biosimilar form of a medicine that has been around for almost two decades, natalizumab (Tysabri). They have the same mechanism of action, and approval by the FDA means that Tyruko is thought to have very similar efficacy and safety to Tysabri.”
Biosimilars are biologic medications that are highly similar to already approved reference products. According to the FDA, biosimilars have no clinically meaningful differences from the reference product, with the same safety and effectiveness. They are made from the same sources and have the same benefits, strength, dosage, and side effects.
In 2010, Tysabri’s annual cost was approximately $34,000, and prices have only increased since then. The biosimilar Tyruko is expected to be significantly cheaper than the reference product. Dr. Giesser explained the importance of the biosimilar’s approval, stating, “This agent is not a new class of disease-modifying therapy, and its primary potential advantage is that if it is less expensive than Tysabri, which is often the case with biosimilar medications, more people with MS may be able to access it.”
The comprehensive care for MS begins with diagnosis and lasts a lifetime. Most individuals with MS experience short periods of symptoms followed by long periods of remission and have a normal life expectancy. Medications such as Tysabri and now Tyruko are crucial for managing acute symptoms and minimizing relapses.
Following the FDA approval of Tyruko, Dr. Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, expressed, “Today’s approval of the first biosimilar product indicated to treat relapsing forms of multiple sclerosis furthers the FDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective, and high-quality medications at potentially lower cost.”
This approval marks a significant milestone, potentially granting widespread access to a more cost-effective treatment for individuals with relapsing forms of MS.
