Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, shares her reaction to the FDA approval of Tyruko (natalizumab-sztn), the first biosimilar approved to treat multiple sclerosis (MS).
Fran Gregory, PharmD, MBA, vice president of emerging therapies at Cardinal Health, explains the importance behind the FDA approval of Tyruko (natalizumab-sztn), the first neurology biosimilar and the first multiple sclerosis (MS) biosimilar to receive regulatory approval in the United States.
Tyruko was developed by Polpharma Biologics and will be marketed globally by Sandoz. The approval marks the fourth FDA approval for a biosimilar in 2023, following Yuflyma (adalimumab-aaty), the autoinjector version of Udenyca (pegfilgrastim-cbqv), and the high-concentration version of Hyrimoz (adalimumab-adaz).
What was your reaction to the FDA approval of the first neurology biosimilar, Tyruko, and why is this approval so important?
This is a really exciting approval. We have not had an approval in the neurology space [before]. This is a natalizumab biosimilar for relapsing forms of multiple sclerosis. It is extremely exciting because MS is such a debilitating disease. It's a very, very difficult disease to treat. These patients have many unmet needs, still, even with the number of treatments on the market today. There's still no perfect treatment for these patients.
So again, adding choices so that those patients can have more opportunity to potentially have a better experience with the biosimilar [or] maybe they see direct cost savings from the biosimilar. But I do think that choice [and] competition open the market to more treatment options for physicians and more options for patients as well.
This biosimilar is extremely big news. I know there's so much focus on the adalimumab biosimilars right now but introducing a brand new therapeutic area, with neurology and a biosimilar, is very, very exciting. And I'm really excited that the manufacturer [will be] able to bring this product to market and get FDA approval for this product. I'm really looking forward to it coming to market and providing more options for patients.