The biosimilar candidate is a VEGF-a inhibitor, intended for the treatment of serious eye diseases such as wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion and myopic choroidal neovascularization*. In 2018 Xbrane signed a co-development agreement with
“Today’s sBLA acceptance marks an important step forward for increasing access to VEGF-a inhibitor therapy for all those who benefit from alternative treatment options,” said Martin Åmark, CEO, Xbrane. “Together with
The FDA filing is supported by a comprehensive Comparative Analytical Assessment of the biosimilar candidate vs. Lucentis (ranibizumab) and positive data from a randomized, double-masked, multi-center study evaluating efficacy, safety, pharmacokinetics, and immunogenicity of the ranibizumab biosimilar in patients with wAMD. The biosimilar candidate met the primary endpoint in the study by demonstrating equivalent efficacy measured in improvement in best corrected visual acuity (BCVA) at week eight compared to Lucentis®. Equivalence was determined because the two-sided 95% confidence interval around the difference in change in BCVA at week eight was within the pre-defined equivalence margin as agreed with the
References
*)
In: ClinicalTrials.gov [Internet]. 2021- [cited
Available from: http://clinicaltrials.gov/show/NCT03805100
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