Xbrane submits ranibizumab biosimilar candidate to FDA

Xbrane Biopharma

29 April 2026 - Xbrane Biopharma has submitted an application for approval to the US FDA for its biosimilar candidate to Lucentis (ranibizumab).

The original application was submitted in April 2023. In October 2025, the company received a so-called complete response letter regarding remaining observations at one of the production facilities.

Read Xbrane Biopharma press release

Michael Wonder

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Michael Wonder