Lupin and Yoshindo’s JV — YL Biologics announces successful outcome of global _=
Phase Ill study for Etanercept biosimilar in Rheumatoid Arthritis . In their board meeting held at Pune last week, YL Biologics (YLB) announced that a global Phase III clinical trial of its investigational Etanercept biosimilar (YLB113) has met with successful outcome. YLB is the joint venture of Pharma major Lupin and Yoshindo in Japan.
“We are excited by the positive results from the Phase III trial. This helps us put together a robust regulatory
dossier intended for global regulatory filings for YLB113. We currently have multiple high value- biosimilar
candidates in our late-stage global development pipeline. We remain committed to advancing our biotech R&D
capabilities so that more patients across the world can access affordable, high-quality biosimilars” said Mr.
Nilesh Gupta, MD of Lupin Limited.
My query to fellow boarders is how long does it take to file the dossier and get regulatory approval since they have completed phase III trial? Also, Nilesh Gupta talks about other biosimilars in the pipeline. Could there be any overlap with Biocon’s product range?