Blog Big Molecule Watch April 24, 2020

Xbrane Biopharma Plans to Continue Phase III Trial of its Xlucane® (Ranibizumab) Biosimilar Product

Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in the EU. The Xplore trial, which was started in 2019, is intended to study the biosimilarity of Xlucane as compared to Novartis’s Lucentis® in wet age-related macular degeneration (AMD), an eye disease that can result in significant vision impairment and blindness in some cases. According to Xbrane, approximately 60% of the planned 580 patients have been recruited, and the company will keep enrollment open and continue treatment for all patients in the study, despite the global coronavirus crisis. Xbrane asserts that the company “will ensure the safety of Xplore study participants as well as the integrity of study data during the COVID-19 pandemic by following recommendations set by the EMA and the FDA.” The company’s press release states that if it completes enrollment in the Xplore trial by the end of the third quarter 2020, Xlucane would still be “on track towards approval ahead of Lucentis® patent expiration in EU July 2022.” Xlucane is Xbrane’s first biosimilar candidate taken into clinical trials.

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