Shots:
The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)Â
Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and IndiaÂ
Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…
Shots:
The EC has approved Mynzepli (AVT06), a biosimilar version of Eylea (aflibercept) for all indications of the reference product in all 30 EEA states; AVT06’s Dossiers are under review in multiple regions incl. the US & Japan
Approval was based on extensive analytical, non-clinical & clinical data incl. a confirmatory study assessing Mynzepli vs…

