Stada and Xbrane have celebrated the approval by the UK’s MHRA of the pair’s Ximluci ranibizumab biosimilar rival to Lucentis in Great Britain. A launch is planned this year.

Having first expected to resubmit the filing by the end of this year, a delay to a key report means Xbrane now expects to deliver its new biologics license application to the FDA during Q1 2023.

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.

Sweden’s Xbrane BioPharma has followed through on plans to tap the equity markets for cash to fuel the planned launch of its Ximluci (ranibizumab) biosimilar version of Lucentis in Europe.