Xbrane Biopharma AB is a biotechnology company which develops and manufactures biosimilars. Xbrane has a patented protein production platform and world-leading expertise within biosimilar development. Xbrane’s headquarter is located in Solna, just outside of Stockholm, and the company has research and development facilities in Sweden and in Italy.
Biosimilars are approved pharmaceuticals that are similar to a biological reference product in terms of quality, safety and efficacy. They are approved in highly regulated markets such as the EU and the US. Biosimilars are so far typically launched with a 20-40% discount vs. the reference biological drug improving significantly the accessibility of the treatments and generating massive cost savings for private and public payors.
Xlucane - Lucentis® - Phase 3 - Global annual sales € 3.2 billion phase III trial was initiated Q1 2019 with primary aim to evaluate comparative efficacy in terms of change in visual acuity 8 weeks after initiation of treatment. Xbrane has acceptance for the study design from both EMA and FDA. The target is to launch the product upon patent expiration in Europe beginning of 2022.
Xbrane has entered into a co-development agreement for Xlucane with the German generic/biosimilar company STADA. Under the agreement Xbrane is responsible for development of the product and STADA for sales and marketing. Development expenses and profits generated from sales of the product are shared 50/50.
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