FDA approves Sandoz's biosimilar of Biogen's blockbuster MS drug Tysabri
Waldemarus
The US Food and Drug Administration has approved Sandozâs (NYSE:NVS) Tyruko, a biosimilar to Biogenâs (NASDAQ:BIIB) blockbuster drug Tysabri, making it the first biosimilar for multiple sclerosis to be cleared for the US market.
The agency said it approved Tyruko for the treatment of certain forms of relapsing MS, along with moderate-to-severe cases of Crohnâs disease in patients who have not responded well to other therapies.
Like Tysabri, Tyruko will also carry a boxed warning that it may increase the risk of developing progressive multifocal leukoencephalopathy, or PML, a potentially deadly viral infection of the brain. As a consequence, healthcare professionals are advised to monitor patients on the drug for signs of the illness, according to the FDA.

Tysabri has been a blockbuster product for Biogen, accounting for approximately $2B of the $8B it reported in product revenue for 2022. The medication was approved by the FDA in November 2004. 
Sandoz, a unit of Novartis (NVS), has been actively developing biosimilars of costly biologic products. The company plans to launch a biosimilar of AbbVieâs (ABBV) Humira, which has generated over $200B in sales since its approval in late 2002, early next year through CVS Healthâs (CVS) new Cordavis biosimilars subsidiary.
Novartis is expected to spin off Sandoz as a separate company in October. 

More on Biogen

Biogen Q2 2023 Analysis: Reata Acquisition, Financials, And Alzheimer's Prospects

Biogen Inc. (BIIB) Q2 2023 Earnings Call Transcript
Biogen And Alzheimer's Disease: Too Early To Celebrate
Will Watershed Moment For Alzheimer's Propel Biogen Stock Higher?
Biogen's Leqembi set for strong uptake based on Baird physician survey
Sanofi was mystery suitor in Reata Pharma bidding war - report
Biogen/ Sage expected to hike price for new depression drug after narrow label
RBC Capital cuts Sage to sector perform, calls FDA decision "major setback"
Seeking Alphaâs Quant Rating on Biogen
Earnings data for Biogen
Dividend for Biogen