Natalizumab Biosimilar to Get FDA Review for MS, Crohn Disease Indications

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The application is under review for relapsing forms of multiple sclerosis and Crohn disease.

The Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for a proposed biosimilar to natalizumab (Tysabri®).

The application for the biosimilar includes the indications for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive disease in adults, as well as moderately to severely active Crohn disease.

Findings from the phase 1 and phase 3 Antelope studies ( Identifier: NCT04115488) in RRMS patients showed that the biosimilar natalizumab was equivalent to the reference product based on efficacy, safety and immunogenicity.

“This is the first and only submission for a biosimilar natalizumab medicine in both the US and Europe,” said Florian Bieber, Global Head of Biopharmaceuticals Development, Sandoz.  “If approved, this biosimilar has the potential to increase access while also delivering savings for health care systems.”

The biosimilar will have the same intravenous dosage form, route of administration, and dosing regimen as the reference product.


Applications for proposed first-of-a-kind multiple sclerosis biosimilar natalizumab accepted by US FDA and EMA. News release. Sandoz. Accessed July 25, 2022.