FDA approved Tyruko for the treatment of multiple sclerosis

Tyruko (natalizumab-site), a natalizumab biosimilar, has been authorized by the FDA as a monotherapy for multiple sclerosis (MS), making it the first neurology biosimilar to get regulatory clearance in the United States.

Sandoz will commercialize Natalizumab, a disease-modifying anti-integrin monoclonal antibody, created by Polpharma Biologics, for treating MS, active progressive illness, and Crohn’s disease in adults.

The biosimilar uses the same intravenous dose form, administration method, dosing schedule, and presentation as the reference medication.

“Hundreds of thousands of the nearly one million people in the United States who have multiple sclerosis experience disease relapse.” Tyruko has the potential to expand the availability of natalizumab medication for these patients, boost healthcare savings, and promote innovation through market competition.” Sandoz North America President Keren Haruvi.

Sandoz submitted a biologics license application for Tyruko in 2022 and revealed plans in September 2019 to market a natalizumab biosimilar. Under the global commercialization agreement for Tyruko, Polpharma Biologics will maintain responsibility for the development, manufacturing, and supply of the active substance, while Sandoz has the right to commercialize and distribute it in all markets.

In November 2019, Polpharma Biologics commenced its phase 3 clinical research comparing the safety and effectiveness of Tyruko, then known as PB006, to the reference drug. The Antelope study comprised patients from 48 locations across seven countries, and the results confirmed the use of PB006 as a suitable substitute for the reference product.

Tyruko is the first and only biosimilar approved to treat relapsing forms of multiple sclerosis, and there are no MS biosimilars approved in the European Union, Canada, or Australia. In April 2023, IQVIA published research that revealed that neurologists in Europe are fully aware of the biosimilar pipeline for MS and want to use it to enhance treatment access for their patients.

The key generic and biosimilar MS medications planned to debut in the next five years are predicted to save between €4.5 billion and €5.5 billion in France, Germany, Italy, Spain, and the United Kingdom between 2023 and 2028.