Stada And Xbrane Gain EU All-Clear For Ranibizumab Biosimilar
Companies Aim To Launch Lucentis Rival In Selected European Markets Early Next Year
The European Commission has approved Stada and Xbrane’s Ximluci ranibizumab biosimilar, the third Lucentis rival to be approved in the region so far. The companies are aiming to launch in early 2023 in selected European markets.
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Xbrane has announced the formal acceptance by the US FDA of its re-filed ranibizumab biosimilar, developed in collaboration with Stada and licensed in North America to Bausch + Lomb.
Xbrane has resubmitted its filing for a ranibizumab biosimilar version of Lucentis to the FDA, suggesting that it could receive approval in the first half of next year.
Stada has celebrated “growing faster than the markets in which it operates” after delivering a 2022 performance that saw the firm’s earnings lifted in particular by increases in its consumer healthcare and specialty segments.