Key takeaways:
Tyruko (natalizumab-sztn) and Tysabri (natalizumab) are medications that treat relapsing forms of multiple sclerosis (MS). Tyruko is a biosimilar to Tysabri that’s slated to become available in the U.S. during the first half of 2024.
Although not identical, Tyruko works in the same way as Tysabri, its original (“reference”) product. Their benefits and side effects were found to be the same in clinical trials.
Tyruko is expected to be a more affordable alternative to Tysabri. Your health insurance plan and infusion center will likely make the final call on which medication is available.
The landscape of multiple sclerosis (MS) treatment options has evolved substantially over the past 30 years. Not only has the number of available treatments increased, but treatments are more effective at preventing the progression of MS than ever.
Tysabri (natalizumab) and Tyruko (natalizumab-sztn) are two of these medications. They’re very similar to each other, too. Tyruko was FDA-approved in August 2023 as the first biosimilar to Tysabri. Tysabri is already available, and Tyruko is slated to follow suit in the first half of 2024.
These medications share many common features. So how do you know if one is better for you? Here are five similarities and differences to consider between Tyruko and Tysabri.
Tysabri is a monoclonal antibody medication that was approved to treat MS in 2004. It’s a type of biologic, which is a complex medication that’s made from natural and living sources.
However, because of how they’re made, biologic medications don’t come as “brand” and “generic” versions. Instead, they come as reference (“original”) biologics and biosimilars. A biosimilar is a biologic product that’s highly similar, but not identical, to a reference biologic.
What does this mean? Tyruko is highly similar to Tysabri in terms of structure and function. One isn’t considered better or safer than the other. Clinically speaking, they’re expected to deliver the same benefits.
The biggest differences between them are cost and availability. Biosimilars are generally more affordable than reference biologics. But the best and cheapest medication for you will depend on your health insurance coverage, as well as what’s available at your infusion center.
Keep in mind: Tyruko is not considered “interchangeable” with Tysabri. You can only switch from one to the other with a new prescription order from your healthcare provider.
Tyruko and Tysabri lessen nerve inflammation in the same way. They bind to integrin proteins in your body and prevent white blood cells from causing brain inflammation.
They’re also administered in the same way. The recommended dosage of Tyruko or Tysabri for MS is 300 mg every 4 weeks. They’re given as an intravenous (IV) infusion over 1 hour. Your treatment with one or the other will usually continue as long as it’s working for you and isn’t causing bothersome side effects.
Good to know: Tyruko and Tysabri lessen gut inflammation using a similar strategy. In addition to MS, they’re both approved to treat people living with Crohn's disease that haven’t responded well to other treatments.
Tyruko and Tysabri are disease-modifying therapies approved to treat relapsing forms of MS. They aim to slow the progression of MS. Both are FDA-approved to treat the following types of MS, each of which has its own symptoms and characteristics:
Clinically isolated syndrome: This refers to the first episode of MS symptoms you may experience. Some people report vision and bladder problems, arm and leg weakness, and coordination challenges that last at least 24 hours.
Relapsing-remitting MS (RRMS): This is the most common type of MS. It’s characterized by relapses in symptoms and periods of remission.
Secondary progressive MS (SPMS): SMPS is similar to RRMS, but it can become more disabling over time. Tysabri and Tyruko are only approved for SPMS during an “active” phase.
Because these types of MS vary in their courses, your treatment will depend on the form of MS you’re currently experiencing. It’s important that Tyruko and Tysabri can treat multiple forms of MS, too. MS is considered a continuous disease. You can move between these types at different periods of time. It’s often an unpredictable and progressive condition. You can be in remission (a recovery state) and then experience a relapse (or exacerbation) unexpectedly.
Good to know: There is a fourth type of MS called primary progressive MS (PPMS). People with PPMS experience worsening symptoms over time and don’t relapse or have periods of remission. Tysabri and Tyruko are not approved to treat this form of MS.
During the FDA approval process, biosimilar manufacturers must show that there are no meaningful differences in safety or effectiveness between their products and the reference biologics.
In a phase 3 clinical trial with over 250 adults with MS, half were treated with Tyruko and half with Tysabri. Over 24 weeks (almost 6 months), no significant differences were found in clinical response or adverse effects between the two groups of people. So, whether you’re prescribed Tyruko or Tysabri, you shouldn’t experience any differences in benefits or risks.
Tyruko and Tysabri have the same side effects. Some of the most common ones are headaches, fatigue, and joint pain. Serious risks are uncommon. But there are risks of new or worsening infections, liver problems, and allergic reactions, among others.
One notable infection to be aware of is progressive multifocal leukoencephalopathy (PML). This rare brain infection is life-threatening. Your healthcare provider will check your blood for the virus that causes PML. If you test positive for the JC virus (JCV), your risk for PML is higher during treatment with Tyruko or Tysabri. Your provider can help you weigh this risk when choosing which MS treatment is best for you.
Because of the risk of PML, close monitoring is important. The FDA requires anyone prescribed Tysabri to be enrolled in the TOUCH Prescribing Program. And Tyruko is only available through the Tyruko Risk Evaluation and Mitigation Strategies (REMS) program. These medication safety programs help make sure the benefits of Tysabri and Tyruko outweigh the risks for people who need them.
Biosimilars tend to be more affordable than their reference biologics. This is primarily because the FDA created an approval pathway for biosimilar products that uses some of the research already done for their reference biologics. This saves time and money during the clinical development process, which often translates to a lower list price.
Still, the most financially sound medication for you will depend on your circumstances. Your health insurance plan may prefer one medication over the other, and this will directly affect your out-of-pocket cost.
So, what does this mean when it comes to which medication you receive? Your insurance plan and infusion center will probably have the final say. But if you’re having trouble with coverage, GoodRx can help you navigate other ways to save on your prescription.
Save with patient assistance programs. If you’re uninsured or underinsured, you may be eligible for Tysabri’s patient assistance program, which offers the medication at no charge.
Save with a co-pay savings card. If you have commercial insurance and meet eligibility requirements, Tysabri’s price is as little as $0 if you use a manufacturer’s savings card.
Tyruko and Tysabri are disease-modifying therapies that are FDA-approved to treat relapsing forms of MS. Tyruko is a biosimilar to Tysabri, meaning they’re highly comparable medications that are expected to provide the same benefits and have the same risks. But two major differences between the medications are access and affordability. Tyruko may be a more affordable alternative after it commercially launches in the U.S. in the first half of 2024.
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