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# Sandoz BLA Filed for Tysabri Biosimilar
- URL: https://www.fdaweb.com/sandoz-bla-filed-for-tysabri-biosimilar/
- Published: 2022-07-25T12:00:00.000Z
- Updated: 2026-09-14T17:53:07.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5152357

FDA has accepted for review a Sandoz BLA for what the company describes as the first biosimilar copy of Biogen’s Tysabri (natalizumab). The submission seeks approval for all indications of the reference product, which include relapsing forms of multiple sclerosis including clinically isolated syndrome, relapsing-remitting MS, active secondary progressive disease in adults, and Crohn’s Disease. A similar submission was also recently accepted by the European Medicines Agency.

Sandoz says the product was developed by Polpharma Biologics. Under a commercialization agreement, Polpharma will maintain responsibility for development, manufacturing and supply, and Sandoz has the rights to commercialize and distribute the product in all markets, it says.

The biosimilar was developed to have the same intravenous dosage form, route of administration, and dosing regimen as the reference medicine, Sandoz says. The BLA includes a comprehensive analytical, preclinical and clinical data package, it says, adding that the Phase 1 and Phase 3 Antelope studies in multiple sclerosis patients met their primary endpoints, “showing that the biosimilar matches the reference medicine in terms of efficacy, safety and immunogenicity.”