Xbrane Biopharma has performed a comprehensive in-vitro biosimilarity study with several pilot scale R&D batches of Xlucane versus several batches of the reference product.
The study demonstrates no significant difference of Xlucane versus the reference product on the most important parameters. In the in-vitro comparability study Xbrane has, in accordance with European Medicines Agency and FDA biosimilar guidelines, used numerous analytical methods comparing the proteins along 5 key dimensions: primary structure (amino-acid sequence), higher order structure (folding of the protein), binding characteristics (binding with the growth factor VEGFa), biological activity (activity in terms of growth inhibition on living cells) and purity. The study demonstrates no significant difference of Xlucane versus the reference product on the most important dimensions; primary structure, higher order structure, binding characteristics and biological activity. The purity was slightly lower compared to the reference product, which is being addressed through few modifications in the purification process during the scale-up of the production process.
The study will act as a basis for upcoming scientific advice with regulatory authorities to seek guidance on the clinical development strategy for Xlucane and as an important foundation for out-licensing deals with commercialization partners.
“This is a major and significant milestone for us as we now have confirmed that we have a reproducible production process for Xlucane that generates a product proving high biosimilarity in-vitro to the reference product. This gives us full comfort for ongoing scale up of the production to commercial scale and the upcoming clinical trials and it allows us to accelerate the out-licensing process of the product.” says Martin Åmark, Xbrane’s CEO.
Xlucane is a ranibizumab biosimilar for treatment of Age related Macula Degeneration (AMD), Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO). The reference product, Lucentis generates annual sales of 3,6 billion USD and will go off patent 2020 in the US and 2022 in Western Europe.