Sandoz nabs first FDA nod for biosimilar of Biogen's MS drug Tysabri
2023-08-24
上市批准并购生物类似药专利到期
The FDA on Thursday approved Tyruko (natalizumab-sztn), a biosimilar that references Biogen's injectable multiple sclerosis (MS) treatment Tysabri (natalizumab). According to the US regulator, the decision makes Tyruko - which is marketed by Novartis' Sandoz unit - the first biosimilar product approved in the country for patients with MS.
Specifically, Tyruko is cleared to treat relapsing forms of MS; namely, clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. Similar to Biogen's drug, Tyruko is also indicated for inducing and maintaining clinical response and remission in adult patients with moderate-to-severe active Crohn's disease who are deemed unsuitable for conventional Crohn's therapies and TNF-α inhibitorsTNF-α inhibitors.
According to the FDA, the approval is based on evidence that showed there are "no clinically meaningful differences" between Tysabri and SandozSandoz's product in terms of safety, purity and potency. "Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of MS," commented Paul Lee, director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research. He added that the approval of Tyruko "could have a meaningful impact for patients managing their disease."
The prescribing information for natalizumab products, including Tyruko and Tysabri, also contains a boxed warning about progressive multifocal leukoencephalopathy. As a result of this risk, the FDA noted that natalizumab products are available only under a risk evaluation and mitigation strategy (REMS).
Biogen, which recently lost a bid to prevent Sandoz from introducing its biosimilar, reported that Tysabri had sales of $483.1 million in the second quarter, down from $516.2 million in the year-ago period. Meanwhile, the EU's drug advisory body last month adopted a positive opinion for SandozSandoz's Tysabri biosimilar.
The Novartis subsidiary, which is expected to spin-off as a separate entity around early October, recently indicated that it is bolstering its biosimilar focus. Aside from biosimilar launches of AbbVie's Humira (adalimumab) and Tysabri, it also plans to introduce follow-on biologics of Bayer and Regeneron Pharmaceuticals' Eylea (aflibercept) as well as Amgen's Prolia/Xgeva (denosumab) in 2024.
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