Polpharma Files for EU Approval of Tysabri Biosimilar

Polpharma Biologics has filed for approval in the EU for its biosimilar of Tysabri, Biogen’s multiple sclerosis (MS) therapy. The application is the first of its kind in the EU, and covers the intravenous version of the drug. Biogen originally had 5 more years of exclusivity, but a key patent for the drug was revoked in a European court last year.

According to Phil Taylor, “The threat of biosimilar competition to Tysabri is a big headache for Biogen, as it copes with the commercial failure of its Alzheimer’s therapy Aduhelm (aducanumab), which has seen its use dramatically restricted in the US, its only market.”

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(Source: Polpharma, July 18th, 2022)