First of a kind multiple sclerosis biosimilar natalizumab accepted by US Food and Drug Association

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Sandoz, a global pharmaceutical company working in generic and biosimilar medicines, announced this week that the US Food and Drug Administration (FDA) has accepted its biologics application (BLA) for treatment for people with multiple sclerosis (MS).

The application is for a biosimilar natalizumab developed by Polpharma Biologics and includes all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of MS including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn’s Disease.


The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab covering treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EMA for reference medicine Tysabri (a registered trademark of Biogen).

Tysabri was developed to have the same intravenous (iv) dosage form, route of administration, dosing regimen and presentation as the reference medicine.

MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system (brain and spinal cord) 3 that can drastically affect an individual’s everyday life and requires life-long treatment. The disease has a wide range of symptoms, beginning with blurred vision, fatigue, weak limbs, unsteadiness and tingling sensations and leading to limited mobility and neurological decline.4 Treatment cost and lack of access to effective treatment can create an additional burden for people with MS, their families and healthcare systems.

Patient access

Sandoz says it is committed to accelerating patient access to potentially life-changing, high-quality treatments, while generating savings for healthcare systems and patients.

Florian Bieber, global head of biopharmaceuticals development, at Sandoz said: “Thanks to advances in medicine over the last 20 years, we now have DMTs, which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge. This is the first and only submission for a biosimilar natalizumab medicine in both the US and Europe. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems.”

The BLA and MAA include a comprehensive analytical, preclinical and clinical data package. The Phase 1 and Phase 3 Antelope studies in RRMS patients met their primary endpoints, showing that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity. 


The company says it is committed to all aspects of the safe use of, and patient experience with, its proposed biosimilar natalizumab. This includes a JCV test and either a REMS (for the US) or RMP (for the EU) program, both of which will be subject to approval by the relevant health authority.

Sandoz entered into a global commercialization agreement for proposed biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibility for development, manufacturing and supply.

Explore other topics: EMAFDAGermanyMultiple sclerosisUSA

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