XBrane and STADA Collaborating to Develop Lucentis® Biosimilar

Today, XBrane Biopharma and STADA Arzneimittel announced that they have entered into a co-development agreement for Xlucane, a proposed biosimilar of Lucentis® (ranibizumab), in which the companies will equally contribute and share in profits from commercialization in a 50/50 split.  According to the press release, Xbrane will be responsible for development of the product until completion of the marketing authorization applications for EMA and the U.S. FDA and for supplying the finished product, whereas STADA will hold the marketing authorizations and be responsible for sales and marketing across all territories covered by the agreement, which includes Europe, the United States, and a variety of markets in the Middle East and North Africa (MENA) and Asia-Pacific (APAC).  The companies report that they are in the process of developing a pivotal phase I/III clinical trial for the biosimilar candidate.