On August 24, the FDA announced that it had approved its 42nd biosimilar—Sandoz’s Tyruko® (natalizumab-sztn), a new biosimilar agent for the treatment of relapsing forms of multiple sclerosis (MS) (an initial clinically isolated occurrence, relapsing-remitting disease, and secondary progressive disease). As with the reference product Tysabri®, Tyruko is also indicated to induce and maintain clinical response in patients with moderate-to-severe Crohn’s disease who have had inadequate response to or are unable to tolerate other conventional treatments. Phase 3 studies were completed in patients with relapsing-remitting multiple sclerosis.
This approval marks several new biosimilar firsts. It is the first integrin-receptor antagonist, as well as the first biosimilar approval for an MS treatment. This will also be the first opportunity for neurologists to prescribe a biosimilar product.
In addition, Biogen’s Tysabri earned $1.1 billion in 2022, but it has only 5% of the total marketshare in the MS category owing to heavy competition and Roche’s leading product Ocrevus®. Another factor limiting utilization of natalizumab is the boxed warning for the increased risk of progressive multifocal leukoencephalopathy, which Tyruko also carries. Therefore, it is also the first US biosimilar entry for a reference product that does not lead the disease category (e.g., infliximab, trastuzumab, bevacizumab, adalimumab, pegfilgrastim, etc).
Launch and pricing information have not been announced yet by Sandoz, which is in the final stages of a spinoff from Novartis. The savings gained from this product may be more limited than we have seen from biosimilar introductions in the past: No other major biosimilar manufacturer has publicly announced its intent to enter this competition. As previously reported, patent litigation between Sandoz and Biogen is outstanding and may affect launch timing. In its own press release, the company stated, “Sandoz is committed to bringing this important medicine to US patients as soon as possible.”
Tyruko was developed by Sandoz’s partner Polpharma Biologics. Sandoz’s biosimilar portfolio now stands at 5 approved products, including adalimumab (Hyrimoz®), filgrastim (Zarxio®), pegfilgrastim (Ziextenzo®), Tyruko, and etanercept (Erelzi®).
