Presentation

Xbrane Biopharma AB develops and manufactures high quality and cost-effective biosimilars based on a patented platform technology. Xbrane’s leading product Xlucane, a Lucentis® biosimilar candidate, addresses the USD >12bn ophthalmic VEGFa inhibitor market. Xlucane’s marketing authorisation is expected around end-2022 with market launch in Q1 2023. In addition, Xbrane has four additional biosimilars in its pipeline with the aim of adding at least one biosimilar each year. The company managed to partner Xlucane with STADA for Europe and with the worldwide ophthalmology leader Bausch+Lomb for North America – securing good commercial prospects.

Recent highlights
In June 2021 the company announced that Xlucane has met its primary endpoint in the phase 3 trial and is thus ready for submission in the US and Europe. But the filings were a bit delayed due to request for complementary information and questions from both the FDA and EMA.

Outlook
We expect Xlucane’s will receive regulatory approval from EMA in November and market launch in Q1 2023. The FDA re-submission is expected in 2H 2022 with market lauch in 2023. Further, it is likely that the company will announce new regional partnering deals for Xlucane, such as for South America in the coming months. Market launch of Xlucane in the USD >10bn aVEGF market which currently dominated by three drugs (Eylea, Lucentis and off-label used Avastin).