Stada And Alvotech Eye Potential EU Ustekinumab Nod This Year
A Frontrunner Filing For A Stelara Biosimilar Has Been Accepted For Review By The EMA
Alvotech and Stada have indicated that they could receive an EMA opinion on their AVT04 Stelara biosimilar as early as the second half of 2023, after the agency confirmed acceptance of their ustekinumab filing.
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Intas has announced that its Accord Healthcare unit has filed in Europe the DMB-3115 biosimilar ustekinumab candidate licensed from Japan’s Meiji Seika Pharma and Korea’s Dong-A.
In a busy week for Alvotech, the firm has announced an expansion of its partnership with Advanz to cover five further European biosimilars, at the same time as revealing two new pipeline assets. Meanwhile, the company has also dropped three products from an existing European partnership with Stada and has also terminated a development deal with BiosanaPharma.
Samsung Bioepis has reported positive Phase I data for its SB17 ustekinumab candidate, a proposed biosimilar to Stelara.