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Stada And Xbrane Gain EU All-Clear For Ranibizumab Biosimilar

Companies Aim To Launch Lucentis Rival In Selected European Markets Early Next Year

 
• By Rosalind Rei

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.

Europe from space sunrise new dawn
A formal European marketing authorization approval has now been granted • Source: Deco / Alamy Stock Photo

The European Commission has granted a marketing authorization for Stada and Xbrane Biopharma’s Ximluci (ranibizumab) 10mg/ml solution for injection biosimilar rival to Lucentis. The authorization covers all 27 EU member states as well as Iceland, Norway, and Lichtenstein.

The authorization comes just over a year after the companies first filed in the EU for the Lucentis rival. (Also see "Xbrane And Stada Celebrate Major Milestone With EU Filing For Lucentis Rival" - Generics Bulletin, 5 October, 2021

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