Biocon Joins Fray For Denosumab, Ustekinumab Biosimilars
Eylea Biosimilar Option Exercised
Biocon is progressing trials for biosimilar rivals to Amgen’s Prolia/Xgeva (denosumab) and J&J’s Stelara (ustekinumab), even as it gears for other large opportunities coming its way via the Viatris deal including for blockbusters Humira and Eylea.
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Alvotech and marketing partner Teva have confirmed that their AVT04 proposed ustekinumab biosimilar rival to Stelara has been filed with the US FDA, ahead of a key patent expiry later this year.
Lupin’s Multicare Pharmaceuticals subsidiary in the Philippines will partner with distributor DKSH to market five Alvotech biosimilars. Alvotech’s biosimilars, which remain at the pre-approval stages, reference Prolia/Xgeva, Eylea, Simponi, and two more undisclosed molecules.
Biocon has revealed that an FDA inspection of key biosimilars manufacturing facilities in Bengaluru and Malaysia in August has resulted in numerous Form 483 observations across three Biocon Biologics sites.