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FDA accepts BLA for first-of-a-kind biosimilar natalizumab to treat indications covered by Tysabri. -Sandoz

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Published:25th Jul 2022

Sandoz, a global leader in generic and biosimilar medicines, announced that the FDA has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.

The application includes all indications covered by the reference medicine Tysabri (natalizumab) for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn´s Disease. The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, as announced on July 15, covering treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EMA for reference medicine Tysabri.

This marks the first time the regulatory agency accepted a marketing authorization application for a biosimilar of Tysabri, an approved MS treatment.

The last of Biogen’s main patents on Tysabri expired in 2020. Based on the completion of its phase III clinical trial, a 351(k) filing may take place this year.

Condition: MS/CIS/Crohns
Type: drug

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