Sandoz Prepares For European Natalizumab Launch As Approval Arrives
Company Offers Indications Of Launch Timing For Tyruko Biosimilar Rival To Tysabri
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.
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As part of a wide-ranging discussion of its biosimilars business as it reported nine-month results, Sandoz has revealed that it is considering launching its Tysabri (natalizumab) biosimilar Tyruko “at risk” in the US, while also providing an update on its progress with adalimumab as well as certain key pipeline assets.
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.
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.