Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Tyruko® approved for all indications of reference medicine Tyruko® biosimilar to treat...
Sandoz`s Tyruko (natalizumab) Receives Approval in Europe
Biogen`s Biologic Tysabri (natalizumab) Receives Approval in the U.S.
Sandoz`s Tyruko (natalizumab) Receives Approval in Europe
Sandoz, a global leader in generic and biosimilar medicines, on Tuesday, announced that the European Commission (EC) granted marketing authorisation for the first and only biosimilar Tyruko (natalizumab), developed by Polpharma Biologics.
The U.S. Food and Drug Administration today approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD) with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-? (tumor necrosis factor, a substance in your body that causes inflammation).
Sandoz's Biologic Tyruko (Natalizumab) Receives Approval in the U.S.
If approved, will be first-of-a-kind biosimilar natalizumab in Europe, for use in all indications of reference biologic Positive CHMP opinion based on evidence from extensive analytical...
Biogen`s Biologic Tysabri (Natalizumab) Receives Approval in the U.S.
March 1 (Reuters) - Roche's Genentech Inc ROGING.UL sued Biogen MA Inc BIIB.O on Tuesday in San Francisco federal court, claiming Biogen owes additional patent royalties from worldwide sales of its blockbuster multiple-sclerosis and Crohn's disease drug Tysabri.