FDA accepts ABLA for natalizumab biosimilar

Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease in adults – and Crohn´s Disease.  The EMA accepted a MAA for the same product earlier this month.