Sandoz Delivers Denosumab Data As Biogen Sues On Tysabri
Company Eyeing 2024 Denosumab Launch; Natalizumab Accepted In US, EU
Having previously identified itself as the frontrunner in the race to launch a biosimilar to Amgen’s Prolia, Sandoz has now delivered positive confirmatory data, shortly after being sued in the US over its Polpharma-partnered proposed Tysabri biosimilar.
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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.
Having already launched one of its denosumab biosimilar products in China, Boan Biotech has now commenced an international Phase III study to secure approval in Europe, the US and Japan.
Months after announcing that its GP2411 biosimilar denosumab candidate was accepted for filing by the FDA, Sandoz has been sued for alleged patent infringement by originator Amgen.