The potential for further biosimilar competition to Lucentis (ranibizumab) in Europe continues to build, with Stada becoming the latest company to submit a marketing authorization application for a biosimilar product, partner Xbrane Biopharma’s proposed Xlucane biosimilar candidate, to the European Medicines Agency.
The Swedish player has disclosed that the MAA was validated by the EMA, confirming “that the application is sufficiently complete to begin a formal review process.” In June, Xbrane reported positive results from the company’s landmark ‘Xplore’ Phase III clinical trials, putting it in a position to begin filing the biosimilar product