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July 26, 2022

FDA accepts BLA for Sandoz’s proposed biosimilar natalizumab

A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions.

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri.

Natalizumab is developed by Sandoz’s collaboration partner Polpharma Biologics.

The biosimilar has an intravenous (IV) dosing form, dosing route, regimen and presentation in line with the reference medicine.

The BLA comprises all indications of Tysabri for relapsing MS types including clinically isolated syndrome (CIS), active secondary progressive disease in adults, relapsing-remitting MS (RRMS) and Crohn’s disease.

On 15 July, the European Medicines Agency (EMA) accepted the marketing authorisation application (MAA) submitted by the company for the proposed biosimilar natalizumab.

Under this MAA, the indications include treatment as a single disease-modifying therapy (DMT) in highly active RRMS adult patients.

This indication is already approved by the regulatory agency for Tysabri.

A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions. 

In Phase I and Phase III Antelope trials that enrolled RRMS patients, primary endpoints were met, indicating that the biosimilar has efficacy, safety and immunogenicity in line with the reference medicine. 

Sandoz Biopharmaceuticals Development global head Florian Bieber said: “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.”

A chronic inflammatory and neurodegenerative ailment of the central nervous system, MS can significantly impact the daily life of a person and needs life-long therapy. 

In 2019, Sandoz and Polpharma Biologics signed an international commercialisation agreement for natalizumab. 

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