EC Approves Polpharma Biologics’ MS-Treating Biosimilar

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The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

Polpharma Biologics, a biotech company headquartered in Poland, announced on Sept. 26, 2023 that the European Commission (EC) approved Tyruko (natalizumab), a biosimilar for treating relapsing forms of multiple sclerosis (MS). The biosimilar was developed by Polpharma Biologics and will be commercialized Sandoz, its collaboration partner.

According to a company press release, Tyruko is the first and only biosimilar for treating relapsing forms of MS in Europe. The specific indication for the product is as a single disease-modifying therapy in adults with highly active relapsing-remitting MS (RRMS), which is the same indication for which the reference biologic, Tysabri (natalizumab), is approved by the EC.

The approval is valid in all European Union member states, as well as the European Economic Area countries of Iceland, Liechtenstein, and Norway, and Northern Ireland under the Northern Ireland Protocol. Outside of Europe, Tyruko was approved in the United States by FDA in August 2023.

Meanwhile, a separate application for the use of biosimilar natalizumab in RRMS has been filed with the Medicines and Healthcare Products Regulatory Agency in the United Kingdom, and the company awaits a decision there as well.


“We are delighted that the European approval of Tyruko comes hot on the heels of approval in the [US], 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,” said Michael Soldan, CEO, Polpharma Biologics Group, in the press release. “Tyruko is the second EMA [European Medicines Agency] and FDA-approved biosimilar produced by Polpharma Biologics and the first one developed entirely in-house. We’re building on this extensive scientific and manufacturing expertise to further advance our pipeline of other high-potential biosimilar targets.”

Source: Polpharma Biologics