Polpharma Biologics Announces EMA Acceptance for Proposed Biosimilar Natalizumab (Tysabri)

Biosimilar natalizumab was developed by scientists at Polpharma Biologics (Poland) and the company retains responsibility for the manufacturing and supply of the medicine. Sandoz has the rights to commercialize and distribute the proposed biosimilar under an exclusive global license, secured through a commercialization agreement signed between Polpharma Biologics and Sandoz in 2019.

European Medicines Agency (EMA) has accepted the first-ever Marketing Authorization Application (MAA) for biosimilar natalizumab, a proposed biosimilar to Tysabri®*, a single disease-modifying therapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS). Due to the high cost of therapies, the economic burden of MS is substantial - between €37,000-57,000 per patient, per year in those with moderate-to-severe disease. Biogen´s patent portfolio around Tysabri is expired in several regions but the revenues did not come down significantly. For 2021 a global revenue estimation sees Tysabri worth for around USD2bn. Biogen has a lot more drugs in MS approved and a single substitution may not weeken their market share too much.

“The acceptance of the filing of proposed biosimilar natalizumab by the European regulatory authorities means we are a critical step closer to getting this important medicine to the patients who need it the most. We are deeply proud of the dedication of our scientific teams to take biosimilar natalizumab from cell line and technical development, through clinical trials to registration - today’s milestone is testament to their achievements,” said Michael Soldan, CEO.

Polpharma Biologics is focused on developing biosimilar therapies to treat some of the world’s most impactful diseases across neurology, immunology and ophthalmology. The company has a robust pipeline containing more than six biosimilars in different stages of development. Another proposed biosimilar  following ranibizumab has been successfully filed in Europe in the past year, and was developed in cooparation with Bioeq and Formycon.

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