- The Food and Drug Administration has approved a Novartis medicine that’s meant to mirror a blockbuster inflammation-regulating therapy from Biogen.
- Marketed by Novartis’ Sandoz division, Tyruko is the first so-called biosimilar to Biogen’s Tysabri cleared for the U.S. market. Both drugs inhibit white blood cells from getting to certain tissues in the body, thereby reducing inflammation. Tysabri was approved first as a multiple sclerosis treatment in 2004, and then again in 2008 as a therapy for moderate-to-severe Crohn’s disease. Tyruko now carries the same two indications.
- While Biogen has sought to stop the launch of Tyruko by claiming Sandoz infringed on its patents, that legal dispute hasn’t favored Biogen. As such, Umer Raffat, an analyst at the investment firm Evercore ISI, believes an FDA approval was the last hurdle keeping Tyruko from directly competing with Tysabri on the U.S. market. Raffat wrote in a note to clients Thursday that a commercial launch of Sandoz’s drug seems “imminent.”
Biogen has leaned more heavily on Tysabri since losing patent protection on its former top-selling MS product Tecfidera. Over the first six months of 2023, 26% of the company’s $3.6 billion in product revenue came from Tysabri.
As is typical in the pharmaceutical industry, Biogen has built a thicket of patents around its medicines. In the U.S., more than a dozen protect the formulation, safety measurements and treatment methods related to Tysabri, with some not expiring until the mid-2030s.
Last September, after Sandoz announced that the FDA had accepted its application to approve Tyruko as a biosimilar to Tysabri, Biogen filed an action in the U.S. District Court for the District of Delaware. The action sought a “declaratory judgment of patent infringement” against Sandoz.
According to Raffat, Biogen a few weeks ago asked for a preliminary injunction that would, in effect, deter Sandoz from selling its copycat medicine. However, that request “did not go well for Biogen.”
“Could there still be scope for some sort of settlement? Or is it too late? Unclear,” Raffat wrote in his note. “But my sense has been that Sandoz is willing to attempt such a launch at risk heading into its spinout from Novartis.”
Raffat also wrote that the net price may drop on Tysabri may lower if a biosimilar enters the market.
Sandoz is currently trying to secure an approval in Europe as well. Last month, key regulators who recommend to the European Union whether medicines should receive marketing authorization put their support behind the company’s biosimilar.
Sandoz secured rights to Tyruko in 2019 through a deal with Polpharma Biologics, the drug’s developer.
Editor’s Note: A previous version of this story misidentified the Novartis division behind Tyruko, and has been corrected. The story has also been updated to mention Tyruko’s developer Polpharma Biologics.