Xbrane skickar in ny ansökan efter FDA-bakslag

Solnaföretaget Xbrane har satt en tidplan för att åter skicka in en ansökan för sin biosimliar för Lucentis.

By Samuel Lagercrantz

November 19, 2025 11:56 AM

I förra månaden fick Xbrane ett hårt bakslag i USA för sin biosimilar till ögonläkemedlet Lucentis (ranibizumab), se tidigare artikel i Life Science Sweden.

Nu planerar företaget att åter skicka in en BLA (Biologics License Application) till den amerikanska myndigheten. Anledningen till bakslaget var att FDA krävde korrigerande åtgärder vid en anläggning som används av en av Xbranes kontraktstillverkare i USA.

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