Novartis wins FDA nod for first biosimilar version of Biogen's MS blockbuster Tysabri

Two months after a federal court in Delaware rejected Biogen’s patent infringement case against Novartis and its biosimilar version of the multiple sclerosis (MS) drug Tysabri, the Massachusetts company will now have to deal with the copycat on the market.

On Thursday evening, the FDA endorsed Novartis’ Tyruko (natalizumab-sztn) as the first U.S. biosimilar to treat multiple sclerosis. The new treatment covers all of Tysabri’s indications for relapsing MS in addition to Crohn’s disease.

Tyruko will be commercialized by Novartis’ subsidiary Sandoz. Last week, Novartis said that the long-planned spinoff of the generics and biosimilars unit would happen on or around Oct. 4.

Sandoz acquired worldwide commercial rights to Tyruko in a 2019 deal with Polpharma Biologics. The Poland-based company will continue to develop and manufacture the biosimilar.

“Tyruko has the potential to extend the reach of natalizumab treatment for (MS) patients, increase healthcare savings and fuel innovation through competition in the market,” Keren Haruvi, the president of Sandoz North America, said in a release.

Tysabri was approved by the FDA for MS in 2004 and four years later for Crohn’s disease. By 2009 it was a blockbuster. In 2022, Tysabri generated (PDF) $2.03 billion, accounting for nearly 25% of the Biogen’s revenue. But sales fell by 8% in the first half of this year to $956 million.

Sandoz’s Tyruco will have the same boxed warning as Tysabri for the risk of a brain infection, progressive multifocal leukoencephalopathy (PML), and will only be available through the an FDA designated Risk Evaluation and Mitigation Strategy (REMS) program.

Launching Tysabri will take a while, the company said. Sandoz must first get approval for its JC virus antibody test, which asses the risk of a patient developing PML.

"We cannot speculate on market entry or pricing," Sandoz said in an email. "We will initiate pricing and reimbursement processes in line with the local regulations following approvals. Our aim with every launch of a biosimilar is to increase patients’ access to critical biologic medicines and introduce competition."

Sandoz is one of the top sellers of generics and biosimilars in the world. Last month, it launched Hyrimoz, becoming one of several companies with a biosimilar version of AbbVie’s Humira.

Earlier this month, Sandoz released phase 3 data that showed its biosimilar version of Regeneron’s eye disease blockbuster Eylea matched up with the reference product. The company is eyeing a 2024 launch of that biosimilar in the U.S amid a patent dispute.