FDA Approves First Biosimilar of Natalizumab for the Treatment of Relapsing Multiple Sclerosis

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The FDA is the first regulatory agency globally to approve natalizumab-sztn as a biosimilar for natalizumab.

The FDA announced the approval of natalizumab-sztn (Tyruko; Polpharma Biologics, Sandoz), the first and only biosimilar of natalizumab (Tysabri) for the treatment of relapsing forms of multiple sclerosis (MS), making the FDA the first regulatory agency to approve the drug worldwide.1

The European Medicines Agency is also expected to approve natalizumab-sztn imminently.1

Medical concept of FDA approved. Food and drugs administration quality control.

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“Targeted therapies are the cornerstone of care for [individuals] with MS, but high medication prices are fueling access issues and health care expenditure. The need to address the rising costs of this devastating disease to patients and societies inspired the scientific teams at Polpharma Biologics to develop an efficacious MS biosimilar,” Michael Soldan, CEO of Polpharma Biologics Group, said in a statement. “We are delighted that the FDA’s approval of [natalizumab-sztn] means clinicians will soon have access to an affordable treatment that can change the lives of [individuals] with relapsing MS.”1

MS is a neurological disease with symptom onset generally starting between the ages of 20 and 40 years. The chronic disease affects all individuals differently, with some having a mild course with little to no disability and others experiencing a worsening disease state that leads to disabilities over time.2

According to a study published in Multiple Sclerosis Journal, approximately 2.8 million individuals live with MS worldwide, with the prevalence increasing since 2013. The investigators found that the mean age of diagnosis is 32 years old, with women twice as likely to live with MS than men.3

Natalizumab-sztn will be available in the United States from Polpharma Biologics’ collaborator Sandoz. The drug is approved as a monotherapy to treat all indications that the reference drug is approved for in relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease. It is also approved for Crohn disease in adults, according to the statement.1

Additionally, the intravenous route of administration is the same as the reference drug. The company also stated that the dosing regimen will also be the same as natalizumab, recommending a 300 mg intravenous infusion over 1 hour every 4 weeks.1,4

According to the prescribing label for natalizumab, the most common adverse reactions included headache and fatigue for both MS and Crohn disease. Other common AEs for MS included arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, and rash.4

The approval is based on analytical, functional, and clinical data. It is also accompanied by the same labeling, safety warnings, and a Risk Evaluation and Mitigation Strategy (REMS) as the reference drug. When launched, natalizumab-sztn will be available through the REMS program, which is managed by Sandoz.1

According to the company, the drug was developed by Polpharma Biologics and retains responsibility for manufacturing and supplying the drug while Sandoz has the right to commercialize and distribute the biosimilar.1

References

1. Polpharma Biologics announces FDA Approval of Tyruko – first and only approved biosimilar to Tysabri for relapsing forms of multiple sclerosis. News release. Polpharma Biologics. August 25, 2023. Accessed August 25, 2023. Email.

2. National Institutes of Neurological Disorders and Stroke. Multiple Sclerosis. Updated January 23, 2023. Accessed August 25, 2023. https://www.ninds.nih.gov/health-information/disorders/multiple-sclerosis

3. Walton C, King R, Rechtman L, Kaye W, et al. Rising prevalence of multiple sclerosis worldwide: Insights from the Atlas of MS, third edition. Mult Scler. 2020;26(14):1816-1821. doi:10.1177/1352458520970841

4. Tysabri. Prescribing Information. Elan Pharmaceuticals Inc; 2004. Accessed August 25, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125104s0576lbl.pdf

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