Novartis-Polpharma's biosimilar of Biogen's MS drug Tysabri gets FDA review
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Novartis (NYSE:NVS) said the U.S. Food and Drug Administration (FDA) accepted an application for a proposed biosimilar to Biogen's (NASDAQ:BIIB) multiple sclerosis (MS) therapy Tysabri (natalizumab).
The Swiss pharma giant's generic unit Sandoz said the biosimilar natalizumab was developed by Polpharma Biologics. The two companies have an agreement for the biosimilar, under which Polpharma maintains responsibility for development, manufacturing and supply, while Sandoz has the rights to commercialize and distribute the product in all markets.

Sandoz said the application includes all uses covered by the reference medicine Tysabri for relapsing forms of MS including clinically isolated syndrome, relapsing-remitting MS, active secondary progressive disease in adults, and Crohn's Disease.
Earlier in July, the European Medicines Agency also accepted the marketing authorization application for this proposed biosimilar natalizumab, the company said in July 25 press release.
MS is a progressive, chronic inflammatory and neurodegenerative disease of the brain and spinal cord (central nervous system).