FDA Approves Tyruko, Novartis' Biosimilar to Blockbuster Tysabri

The Food and Drug Administration (FDA) has given the green light to Novartis for its drug Tyruko, a biosimilar of Biogen’s blockbuster Tysabri, paving the way for more competitive pricing in the US market. Tysabri, a prominent inflammation-regulating therapy, was initially approved in 2004 as a multiple sclerosis treatment and subsequently in 2008 for moderate-to-severe Crohn’s disease.

Novartis' Tyruko, developed by its Sandoz division, carries identical indications. Both drugs function by preventing white blood cells from reaching specific body tissues, hence reducing inflammation. Biogen had previously attempted to thwart Tyruko's launch by alleging patent infringement by Sandoz. However, these claims did not hold up in court. A note from Umer Raffat, an analyst at investment firm Evercore ISI, highlighted that with FDA's endorsement, Tyruko's US market launch appears to be on the horizon.

Biogen, having recently lost patent protection on its once best-selling MS product Tecfidera, has increasingly relied on Tysabri. In the first half of 2023 alone, Tysabri constituted 26% of the company's $3.6 billion product revenue. In a typical pharmaceutical strategy, Biogen secured numerous patents for Tysabri in the US, some lasting until the mid-2030s. Despite this, last September, after Sandoz received FDA acceptance for Tyruko, Biogen pursued a “declaratory judgment of patent infringement” against them. 

In a recent twist, Raffat disclosed that Biogen sought a preliminary injunction to deter Sandoz from selling Tyruko, a request that was not in their favor. The introduction of Tyruko to the market could lead to a drop in Tysabri's net price. Sandoz, while preparing for its impending spinoff from Novartis, is also seeking approval for Tyruko in Europe. European Union regulators have already shown their support for the drug last month. A significant point to note is that Sandoz secured global commercial rights for Tyruko in 2019 through an agreement with Polpharma Biologics, based in Poland. 

Polpharma will persist with the development and manufacturing of the biosimilar. Keren Haruvi, President of Sandoz North America, expressed optimism about Tyruko, believing it can enhance the accessibility of natalizumab treatment for MS patients, foster savings in healthcare, and drive innovation through market competition.