European Commission approves first biosimilar for MS drug Tysabri

Following quickly on the heels of US biosimilar approvals, Amsterdam-based Polpharma Biologics scored a European Commission authorization for its Tysabri (natalizumab) biosimilar for multiple sclerosis, the company announced Tuesday.

The biosimilar, marketed as Tyruko, was developed by Polpharma but will be commercialized by its partner Sandoz, thanks to a 2019 agreement. The FDA approved Tyruko in August, making it the first-ever natalizumab biosimilar in the US. The EC authorization also marks the first biosimilar for the drug to come to market in Europe.

Tysabri, owned by Biogen, was approved for multiple sclerosis in 2004 and Crohn’s disease in 2008. It’s a top asset for Biogen, bringing in about $950 million globally in multiple sclerosis in the first half of 2023. The average cost for Tysabri in multiple sclerosis is $117,000 in the first year and then $106,000 the next year.

According to Polpharma, Tyruko is authorized for adults with highly active relapsing remitting multiple sclerosis, the same indication as Tysabri in Europe. It has the same strength, dosage and intravenous administration as Tysabri.

Michael Soldan

“We are delighted that the European approval of Tyruko comes hot on the heels of approval in the U.S, meaning that millions of people living with multiple sclerosis around the world may soon have the option of a more affordable treatment for their disease,” Polpharma CEO Michael Soldan said in a statement. “Tyruko is the second EMA and FDA-approved biosimilar produced by Polpharma Biologics and the first one developed entirely in-house.”

Polpharma is still waiting on approval from the UK’s Medicines and Healthcare products Regulatory Agency, but a decision is “imminent,” according to the company.

The authorization in Europe was based on data from a Phase I study and a confirmatory Phase III study, which both hit their primary endpoints.

Biogen tried to stop Sandoz and Polpharma from getting their biosimilar in the market, filing a patent infringement case last year at the US District Court of Delaware after Sandoz submitted a BLA. In June, the court declined Biogen’s request for a preliminary injunction.

Tysabri is embroiled in another court case with Roche. Roche claims that Biogen used licensed technologies to manufacture the antibody and is owed royalties, interests and costs, according to a lawsuit filed in February.

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