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Natalizumab-sztn Receives FDA Approval as First Biosimilar for Multiple Sclerosis

The approval was based on evidence showing no clinically meaningful differences between natalizumab-sztn and the reference drug in terms of safety, purity, and potency. ....

John Kramer , Patricia Melville , Aliza Ben Zacharia , Paulr Lee , Amy Perrin Ross , Sarah Yim , Sandoz Inc , Division Of Neurology , Office Of Therapeutic Biologics , Drug Evaluation , Therapeutic Biologics ,