By Adria Calatayud

Novartis's Sandoz generic-drugs unit has received approval from the U.S. Food and Drug Administration for biosimilar medicine Tyruko to treat relapsing forms of multiple sclerosis.

Sandoz said Friday that the drug--which was developed by Polpharma Biologics and for which the Swiss company entered into a global commercialization agreement in 2019--is approved to treat all indications covered by reference medicine Tysabri for relapsing forms of multiple sclerosis. Biosimilars are near-replicas of already approved biologic drugs.

This makes Tyruko the first FDA-approved biosimilar for relapsing forms of multiple sclerosis, Sandoz said. The approval was based on robust Phase 1 and 3 clinical studies, the company said.

Write to Adria Calatayud at adria.calatayud@dowjones.com

(END) Dow Jones Newswires

August 25, 2023 01:47 ET (05:47 GMT)

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