Sandoz and Polpharma win FDA approval for Tysabri biosimilar

The US Food and Drug Administration (FDA) has approved Tyruko, a biosimilar version of Biogen’s Tysabri (natalizumab) for the treatment of relapsing forms of multiple sclerosis and adult Crohn disease.

Tysabri, an anti-α4 integrin monoclonal antibody disease-modifying therapy (DMT) first approved in the US in 2004, generated $2.03 billion in sales for Biogen in 2022.

Sandoz and its partner Polpharma will now hope to chip away at these revenues following the approval of its biosimilar Tyruko last month.

DepositPhotos/Zerbor

Under the terms of the agreement entered in 2019 by the Polish manufacturer and the future Novartis spin-off, Polpharma is responsible for the development, manufacturing and supply of the active substance in Tyruko, while Sandoz has the rights to commercialize and distribute it in all markets.

According to Polpharma’s website, the firm has mammalian manufacturing capabilities in Gdansk and Warsaw within its native Poland. The Warsaw plant is described as “one of the largest biologics manufacturing sites in Europe,” boasting three 500 L and four 2,000 L single-use bioreactors and expansion available to 30,000 L.

“We are delighted that the FDA’s approval of Tyruko means clinicians will soon have access to an affordable treatment that can change the lives of people with relapsing MS. We will support our partner Sandoz to bring Tyruko to patients as quickly as possible,” said Michael Soldan, Polpharma’s CEO.

Keren Haruvi, president of Sandoz North America, added: “Of the nearly one million people in the US living with multiple sclerosis, hundreds of thousands experience disease relapse. Tyruko has the potential to extend the reach of natalizumab treatment for these patients, increase healthcare savings and fuel innovation through competition in the market.”

The approval was granted on the basis of robust analytical, functional, and clinical data, according to the FDA.

Approval in Europe is also on the horizon. The European Medicines Agency (EMA) gave a positive opinion on granting marketing authorization for natalizumab, based on a scientific recommendation shared with the European Union.