Biotech company Xbrane Biopharma intends to resubmit its Biologics License Application (BLA) for its ranibizumab biosimilar to the U.S. Food and Drug Administration (FDA) in April or May 2026, according to a press release.

The delay stems from the fact that the company's contract manufacturer must address outstanding observations from the agency related to another product at the same facility. The remaining corrective actions are expected to be completed and verified at the site by late April. Following the resubmission of the BLA, a review period of approximately six months is anticipated.

Xbrane's ranibizumab biosimilar has been approved by the EMA and MHRA since November 2022 and has been in commercial use in those regions since March 2023.