FDA approves first biosimilar for MS

Aug. 25, 2023

Sandoz announced this week that it has received FDA approval for Tyruko, now the first biosimilar greenlighted to treat relapsing forms of multiple sclerosis (MS), offering treatment for all indications covered by the reference medicine. 

The reference drug, Tysabri, was initially developed by Biogen. Tyruko shares the same intravenous dosage form, administration route, dosing regimen, and presentation as the reference medicine. Back in 2019, Sandoz and Polpharma Biologics entered a worldwide commercialization agreement for the biosimilar. Under this arrangement, Polpharma handled development, manufacturing and supply, while Sandoz was put in charge of marketing and distribution. 

Tyruko, like Tysabri, will carry a boxed warning due to the higher risk of a severe brain infection called progressive multifocal leukoencephalopathy (PML). Factors like anti-JCV antibodies, extended therapy, and prior immunosuppressant use increase PML risk. 

The FDA granted Sandoz approval based on data encompassing analytical, functional, and clinical effectiveness, covering various relapsing forms of MS. This includes clinically isolated syndrome, which involves the first MS symptom occurrence; relapsing-remitting disease, characterized by alternating symptom episodes and stability phases; and active secondary progressive disease, where gradual disability worsening and ongoing relapses follow an initial relapsing-remitting pattern.

MS is a chronic autoimmune disorder affecting the central nervous system, causing communication disruptions between the brain and body. It's a prevalent cause of neurological disability in young adults, occurring more in women. Typical MS involves relapses with deteriorating function and new symptoms, followed by remission. However, over time, incomplete recovery can result in a gradual decline in function and heightened disability.

Tyruko and reference drug Tysabri are also indicated for the treatment of moderately to severely active Crohn’s Disease showing inflammation evidence, and who haven't adequately responded to, or can't tolerate, standard CD treatments and TNF-α inhibitors.

Sandoz, Novartis’ generics business, is slated to become Europe's largest generics company by sales. If all goes well during an upcoming meeting of its shareholders, Novartis says the spin-off — which will separate Sandoz into a new, publicly traded standalone company headquartered in Switzerland — will occur on or around October 4, 2023.