If you live with multiple sclerosis (MS), you may have heard of biologic treatments. Biologics are medications made from living sources, some of which are designed to target specific parts of the immune system. A biosimilar is very similar, but not identical, to an original biologic medication (also known as a reference product) that the U.S. Food and Drug Administration (FDA) has already approved, with no clinically meaningful differences in safety or efficacy.
MS is a chronic condition that affects the central nervous system and can cause symptoms such as fatigue, mobility challenges, vision changes and cognitive difficulties. While there is no cure, disease-modifying therapies (DMTs), including biologics, can help reduce disease activity and slow disability.
For many people with MS, DMT therapies have become an important part of managing the condition. However, barriers like high cost of and access to DMTs, including biologics, continue to exist. Biosimilars have the potential to become part of routine MS care, helping more patients access the same standard of biologic treatment potentially at a lower cost.
For many people living with MS, treatment decisions aren’t one-time events. Care often evolves over years, shaped by how your MS changes, how your life changes, and how medicine continues to advance.
What Are Biosimilars?
According to the FDA, biosimilars are biological products that are highly similar to an already FDA-approved biologic (known as the reference product). While they are not exact copies – because biologics are complex and made from living systems that have slight variations – biosimilars have no clinically meaningful differences from the reference product in terms of safety, quality and efficacy.
Before approval, biosimilars go through a rigorous evaluation process that includes analytical and clinical studies followed by ongoing monitoring after approval. The FDA only approves a biosimilar once it meets strict standards showing it works the same way in the body as the reference medicine. For patients, this means biosimilars are held to the same high approval standards as the reference treatment.
“People living with multiple sclerosis have unique needs, goals, and circumstances when it comes to choosing a treatment,” said Leslie Ritter, Vice President of Healthcare Access at the National MS Society. “It’s important that people with MS have access to clear information about all available treatment options—including biosimilars—so they can have informed conversations with their healthcare providers. Understanding the potential benefits, risks, costs, and access considerations of each option can help people make the decisions that are right for them.”
Have Biosimilars Been Developed for MS?
Yes. A biosimilar is now available for MS and it may come up in different situations—whether you’re starting treatment for the first time or talking with your care team about your current treatment plan. As with any MS treatment decision, the most important part is having open, informed conversation with your neurologist and care team about what feels right for you.
If you’re already on a biologic therapy, moving to a biosimilar doesn’t mean starting over—it means continuing your current treatment. These transitions happen under the guidance of your neurologist, infusion center, and care team, and decisions are personal, often shaped by factors like insurance coverage, access and comfort level.
The First FDA-Approved Biosimilar for MS: TYRUKO® (natalizumab-sztn)
The first and only FDA-approved natalizumab biosimilar in the US for relapsing forms of MS is TYRUKO®. TYRUKO® is approved for all indications of the reference natalizumab medicine, and has been shown to be clinically equivalent in terms of safety and efficacy.
TYRUKO is used to treat adults with relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TYRUKO increases the risk of progressive multifocal leukoencephalopathy (PML). When starting and continuing treatment with TYRUKO, it is important to discuss with your doctor whether the expected benefit of TYRUKO is enough to outweigh this risk.
TYRUKO® increases your risk of getting a rare brain infection – called PML – that usually leads to death or severe disability. Please see complete safety information below.
Like the reference product, TYRUKO is available only through a Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of PML. Your healthcare provider can help explain what the REMS program involves, how monitoring works, and whether natalizumab treatment is appropriate for your individual care plan.
Sandoz, the manufacturer of TYRUKO® has partnered with Labcorp, a global leader of innovative and comprehensive laboratory services, to develop and validate a laboratory-developed test (LDT) for detecting the presence of anti-JCV antibodies. Labcorp will offer the TYRUKO® JCV Testing Program at no cost to eligible patients, with Sandoz covering the cost of the test.
How Can I Learn More About Biosimilars for MS?
If you’re curious about biosimilars, reliable education is key. The FDA offers patient-friendly resources that explain how biosimilars are developed, approved and monitored for safety. These tools can help you better understand your options and prepare for conversations with your neurologist.
Living with MS often means making thoughtful, ongoing decisions about care. As treatment options continue to evolve, biosimilars may offer another pathway—one that maintains the efficacy of biologic treatment while potentially improving access and affordability. As always, the best next step is an open discussion with your healthcare team about what feels right for you and your MS journey.
ABOUT TYRUKO® (NATALIZUMAB-SZTN)
TYRUKO® has been developed to match the reference medicine, an established anti-α4 integrin monoclonal antibody disease modifying treatment in relapsing forms of multiple sclerosis (MS). TYRUKO is indicated in the US as monotherapy for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
USES
What is TYRUKO?
TYRUKO (natalizumab-sztn) is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. TYRUKO increases the risk of progressive multifocal leukoencephalopathy (PML). When starting and continuing treatment with TYRUKO, it is important to discuss with your doctor whether the expected benefit of TYRUKO is enough to outweigh this risk.
It is not known if TYRUKO is safe and effective in children under 18 years of age.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TYRUKO?
TYRUKO (natalizumab-sztn) increases your risk of getting a rare brain infection—called progressive multifocal leukoencephalopathy (PML)—that usually leads to death or severe disability.
- There is no known treatment, prevention, or cure for PML
- You should not take certain medicines that weaken your immune system at the same time you are taking TYRUKO. Even if you use TYRUKO alone to treat your multiple sclerosis (MS), you can still get PML
- Your risk of getting PML is higher if you:
- have been infected by the John Cunningham Virus (JCV). JCV is a common virus that can cause PML in people who have weakened immune systems, such as people taking TYRUKO. Before or while you receive TYRUKO, your doctor may do a blood test to check if you have been infected by JCV
- have received TYRUKO for a long time, especially for longer than 2 years
- have received certain medicines that can weaken your immune system before you start receiving TYRUKO
- Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors that have not yet been identified
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- Patients who are anti-JCV antibody negative are still at risk for the development of PML due to the potential for a new JCV infection or a false negative test result. Therefore, patients with a negative test result should be retested periodically
- While you receive TYRUKO, and for 6 months after you stop receiving TYRUKO, it is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days
These may include problems with your thinking, eyesight, balance, or strength; weakness on 1 side of your body; and problems using your arms and legs
Tell all of your doctors that you are getting treatment with TYRUKO
- Because of your risk of getting PML while you receive TYRUKO, TYRUKO is available only through a restricted distribution program called the TYRUKO® REMS Program
Who should not receive TYRUKO?
Do not receive TYRUKO if you have PML or are allergic to natalizumab products or any of the ingredients in TYRUKO.
What should I tell my doctor before receiving each dose of TYRUKO?
Before receiving TYRUKO, it is important to tell your doctor if you:
- have a medical condition that can weaken your immune system, such as HIV (human immunodeficiency virus) infection or AIDS (acquired immunodeficiency syndrome), leukemia or lymphoma, or organ transplant
- have any new or worsening medical problems that have lasted several days
- are pregnant or plan to become pregnant. TYRUKO may cause low platelets (thrombocytopenia) and low red blood cells (anemia) in your newborn baby if you take TYRUKO while you are pregnant. It is not known if TYRUKO can cause birth defects
- have had hives, itching, or trouble breathing during or after receiving a dose of TYRUKO
- have a fever or infection (including shingles or any unusually long-lasting infection)
- are breastfeeding or plan to breastfeed. TYRUKO can pass into your breast milk. It is not known if the TYRUKO that passes into your breast milk can harm your baby. Talk to your doctor about the best way to feed your baby while you receive TYRUKO
Tell your doctor about all of the medicines and supplements you take. Especially tell your doctor if you take medicines that can weaken your immune system. Ask your doctor if you are not sure.
What are the possible side effects of TYRUKO?
TYRUKO can cause serious side effects. If you have any of the symptoms listed below, call your doctor right away:
- Herpes infections. TYRUKO may increase your risk of getting an infection of the brain or the covering of your brain and spinal cord (encephalitis or meningitis) caused by herpes viruses that may lead to death. Symptoms include sudden fever, severe headache, or confusion. Infection of the eye caused by herpes viruses leading to blindness in some patients has occurred. Call your doctor if you have changes in vision, eye redness, or eye pain
- Liver damage. Symptoms include yellowing of the skin and eyes (jaundice), unusual darkening of the urine, nausea, feeling tired or weak, or vomiting
- Allergic reactions including serious allergic reactions. Symptoms of an allergic reaction can include: hives, itching, trouble breathing, chest pain, dizziness, wheezing, chills, rash, nausea, flushing of skin, low blood pressure
Serious allergic reactions usually happen within 2 hours of the start of your infusion, but they can happen any time after receiving TYRUKO. Contact your doctor right away if you have any symptom of an allergic reaction, even if it happens after your infusion
- Infections. TYRUKO may increase your risk of getting an unusual or serious infection because TYRUKO can weaken your immune system
- Low platelet counts. TYRUKO may cause the number of platelets in your blood to be reduced. Symptoms include easy bruising, small scattered spots on your skin that are red, pink or purple, heavier menstrual periods than are normal, bleeding from your gums or nose that is new or takes longer than usual to stop, or bleeding from a cut that is hard to stop
The most common side effects of TYRUKO are:
- Headache, feeling tired, urinary tract infection, joint pain, lung infection, depression, pain in your arms or legs, diarrhea, vaginitis, rash, stomach area pain. If you experience any side effect that bothers you or does not go away, tell your doctor
These are not all of the possible side effects with TYRUKO. Always contact your doctor if you have questions or experience any side effects that bother you or do not go away.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Sandoz at 1-800-525-8747.
Please see full Prescribing Information.