FDA批准Tyruko（natalizumab-sztn），作为Tysabri的生物类似药

August 25, 2023 - Sandoz, a global leader in generic drugs and biosimilars, today announced that the U.S. Food and Drug Administration (FDA) has approved its biosimilar Tyruko (natalizumab-sztn) developed by Polpharma Biologics.

Tyruko is approved for the treatment of all indications covered by the reference drug, and is the first and currently only biosimilar drug approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS).

Keren Haruvi, president of Sandoz North America, said: "Of the nearly one million patients with multiple sclerosis in the United States, hundreds of thousands experience disease relapses. Tyruko has the potential to expand access to natalizumab treatment for these patients, increase medical savings through market competition and stimulate innovation."

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Tyruko is approved as monotherapy for all relapsing MS indications covered by reference medicine Tysabri (natalizumab), including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease, as well as Crohn's disease in adults.

Bari Talente, executive vice president of advocacy and access to care at the National Multiple Sclerosis Society, said: "Access to affordable, high-quality care is critical for people with multiple sclerosis to live their best lives. The approval of Tyruko marks the first FDA-approved biosimilar disease modification for patients with relapsing forms of multiple sclerosis. Treatment, is a milestone. Biosimilars are important treatment options because they are not clinically meaningfully different from their reference drugs. Prescribing these drugs can increase access to affordable medications, improve treatment compliance, and help control healthcare costs."

FDA approval is based on a comprehensive data package that includes analytical, functional and clinical data. The approval comes with a label containing safety warnings and a Risk Evaluation and Mitigation Strategy (REMS).

Tyruko has the same intravenous (IV) dosage form, route of administration, dosing schedule and packaging as the reference drug. Sandoz is committed to all aspects of patient safety with Tyruko, which will be available through Sandoz's REMS program once launched.

Multiple sclerosis is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system that can seriously affect daily life. 2 Most people with multiple sclerosis experience periods of new symptoms or recurrences (partial or complete improvement), followed by periods of disease remission.

Sandoz entered into a global commercialization agreement with PolpharmaBiologics in 2019 for Tyruko. Under the agreement, PolpharmaBiologics will continue to be responsible for the development, production and supply of Tyruko's active ingredients. Sandoz has the rights to commercialize and distribute the drug in all markets through an exclusive global license. Sandoz is committed to bringing this important medicine to American patients as quickly as possible.

About Tyruko (natalizumab-sztn)

Tyruko was developed to be highly similar to its reference drug, an established, highly effective anti-α4 integrin monoclonal antibody disease-modifying therapy in the treatment of relapsing forms of multiple sclerosis (MS). Tyruko is indicated in the United States as monotherapy for relapsing forms of multiple sclerosis, including clinically isolated syndrome (CIS), relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease, as well as Crohn's disease in adults. It is the first and currently only biosimilar drug approved by the FDA for relapsing forms of multiple sclerosis.

Indications

Multiple Sclerosis (MS)

TYRUKO is indicated as monotherapy for the treatment of adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Natalizumab products may increase the risk of progressive multifocal leukoencephalopathy (PML). Therefore, natalizumab is only available through dedicated Risk Evaluation and Mitigation Strategies (REMS) programs. When initiating and continuing treatment with TYRUKO, physicians should consider whether the expected benefits of TYRUKO are sufficient to offset this risk.

Crohn's disease (CD)

Tyruko is indicated for the induction and maintenance of clinical response and remission in adult patients with moderately to severely active Crohn's disease with evidence of inflammation who have an inadequate response to or intolerance to conventional CD therapies and TNF-alpha inhibitors. Tyruko should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate) or TNF-α inhibitors.

Contraindications

Patients who have or have had PML. Patients who have experienced a hypersensitivity reaction to natalizumab products.

Warnings and Precautions

Herpes Infections: Life-threatening and fatal cases of herpes encephalitis and meningitis infections have occurred. Blindness has occurred in patients who developed acute retinal necrosis. If these infections occur, Tyruko should be discontinued and treated appropriately. Hepatotoxicity: Significant liver injury, including liver failure requiring transplantation, has occurred. Discontinue Tyruko in patients with evidence of hepatic impairment.

Hypersensitivity reaction: A severe hypersensitivity reaction (e.g., anaphylactic shock) has occurred. If such a reaction occurs, Tyruko should be permanently discontinued.

Immunosuppression/Infections: Natalizumab products may increase the risk of certain infections. Because use of Tyruko increases the risk of infection, patients should be monitored for the development of infection.

Thrombocytopenia: Natalizumab products may cause thrombocytopenia. Monitor patients for bleeding abnormalities. Discontinue Tyruko in patients with thrombocytopenia.

Adverse reactions

In MS studies, the most common adverse reactions (incidence ≥10%) with natalizumab include headache, fatigue, joint pain, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, limb pain, abdominal discomfort, non-specific diarrhea and rash. In CD studies, the most common adverse reactions (incidence ≥10%) included headache, fatigue, upper respiratory tract infection, and nausea.

Use in Specific Populations

Pregnancy: May cause fetal harm.