Sandoz Reports the US FDA and EMA's Acceptance of BLA & MAA for Natalizumab, a Proposed Biosimilar to Tysabri to Treat Multiple Sclerosis
- The US FDA has accepted the BLA for proposed biosimilar natalizumab that comprises all indications covered by reference natalizumab for MS incl. CIS, RRMS, active secondary progressive disease & CD. The therapy was being developed by Polpharma Biologics
- The EMA also accepted the MAA for the proposed biosimilar natalizumab in RRMS. The submission was based on the comprehensive data package incl. P-I & III (Antelope) study which met their 1EPs & showed that the biosimilar was equivalent to the reference natalizumab in terms of efficacy, safety & immunogenicity
- If approved, the biosimilar can increase access & deliver savings for healthcare systems. Under the 2019 agreement with Polpharma, Sandoz has the rights to commercialize the biosimilar in all markets
Ref: Globe Newswire | Image: Sandoz
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