Polpharma Biologics CEO Discusses Natalizumab Milestone
Q&A With Michael Soldan After CHMP Positive Opinion On Tysabri Biosimilar
In the wake of a positive opinion from the EMA’s CHMP recommending granting a marketing authorization for the firm’s Sandoz-partnered natalizumab biosimilar, Polpharma Biologics CEO Michael Soldan talks to Generics Bulletin about the significance of the development.
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As it announced the formal European Commission approval of its partnered Polpharma Biologics-developed Tyruko natalizumab biosimilar to Tysabri, Sandoz offered Generics Bulletin a timeframe for its expected launch in Europe.
Sandoz and Polpharma Biologics have obtained US Food and Drug Administration approval for their Tyruko natalizumab biosimilar rival to Biogen’s Tysabri. The approval follows a recent endorsement from the European Medicines Agency.
At an eventful European Medicines Agency committee meeting in July, three biosimilars from Biocon, Sandoz and Fresenius Kabi have become the first for each respective molecule – aflibercept, natalizumab and tocilizumab – to gain the endorsement of the CHMP.