Novartis: BLA accepted for biosimilar for MS

(CercleFinance.com) - Novartis says that its Sandoz subsidiary has received approval from the US Food and Drug Administration (FDA) for a biosimilar to natalizumab, developed by Polpharma Biologics, for the treatment of multiple sclerosis (MS).


This application includes all indications covered by the reference drug Tysabri (natalizumab) for relapsing forms of MS, including clinically isolated syndrome (CIS) and Crohn's disease.

In addition, the European Medicines Agency has also accepted the marketing authorisation application for this proposed biosimilar natalizumab as a single disease-modifying therapy in adults with highly active RRMS.

The share is up only 0.3% on this news, however, bang in line with the market in Switzerland this lunchtime.


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