EU approves Ximluci, third biosimilar referencing Lucentis

11 November 2022

The European Commission has granted a marketing authorization for Ximluci (ranibizumab), a biosimilar candidate referencing Lucentis, developed by Germany’s STADA Arzneimittel (SAZ: Xetra) and Sweden’s Xbrane Biopharma (Nasdaq Stockholm: XBRANE).

Indicated for the treatment of various ophthalmic conditions such as neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME), Lucentis is marketed by Roche (ROG: SIX) in the USA and Swiss rival Novartis (NOVN: V) elsewhere.

The EC nod follows the positive opinion issued by the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in September 2022.

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