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Sandoz’s application for MS biosimilar accepted by FDA

The proposed ‘first-of-a-kind’ biosimilar matched the reference medicine, Biogen’s Tysabri, in terms of efficacy, safety and immunogenicity


Sandoz’s biologics licence application (BLA) has been accepted by the US Food and Drug Administration (FDA) for a proposed ‘first-of-a-kind’ biosimilar natalizumab, developed by Polpharma Biologics, for the treatment of multiple sclerosis (MS).

The application incorporates all indications covered by the reference medicine, Biogen’s 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.

A marketing authorisation application (MAA) for natalizumab was accepted on 15 July 2022 by the European Medicines Agencies (EMA), as a single disease-modifying therapy (DMT) in adults with highly active RRMS.

MS is a debilitating, neurodegenerative and inflammatory disease where the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body. MS affects 700,000 people in Europe and approximately 2.5 million people worldwide.

Relapsing forms of MS are characterised by clearly defined but unpredictable attacks of worsening neurologic function, followed by partial or complete recovery periods. Approximately 85% of patients are initially diagnosed with relapsing forms of MS, compared with 10-15% with progressive forms of the disease.

Both applications were supported by a comprehensive analytical, preclinical and clinical data package, including positive results from the phase 1 and phase 2 Antelope studies in RRMS patients. Each study met its primary endpoints, demonstrating that the biosimilar matches the reference medicine, Biogen’s Tysabri, in terms of efficacy, safety and immunogenicity.

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.”

Sandoz and Polpharma Biologics signed a global commercialisation agreement for the proposed biosimilar natalizumab in 2019. As part of that agreement, Polpharma Biologics will develop, manufacture and supply the biosimilar, while Sandoz will commercialise and distribute the biosimilar in all markets through an exclusive global licence.

Article by
Emily Kimber

25th July 2022

From: Research, Regulatory



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