FDA Reviews Natalizumab For Sandoz And Polpharma
Firms Follow First EU Submission With BLA Acceptance In The US
Sandoz and Polpharma have quickly followed news of a European natalizumab filing with confirmation that the proposed biosimilar version of Tysabri has also been accepted for review by the US Food and Drug Administration.
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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.
As Biogen provided an update on a potential sale of its biosimilars business – with the firm “engaged with multiple interested parties” – it also revealed Q2 sales and offered insights into off-patent competition to its Tysabri and Tecfidera brands.
Sandoz and Polpharma’s September 2022 lawsuit over their proposed biosimilar to Biogen’s Tysabri (natalizumab) has moved a step forward in their favor, after a US court denied the originator’s bid to block a pathway to market for their proposed monoclonal antibody while proceedings continue.