Lupin’s JV yields pos­i­tive re­sults for Etan­er­cept clin­i­cal tri­als

BioSpectrum (India) - - COMPANY NEWS -

YL Bi­o­log­ics (YLB), a joint ven­ture by drug maker Lupin and Yoshindo, has suc­cess­fully com­pleted the late phase clin­i­cal stud­ies on a biosim­i­lar ver­sion of Etan­er­cept (YLB113). YLB is a joint ven­ture com­pany founded by Yoshindo and Lupin in 2014, which fo­cuses on clin­i­cal de­vel­op­ment, NDA fil­ing and PMDA ap­proval, and sales and mar­ket­ing of biosim­i­lar drugs in Japan.

The global Phase III study of YLB113 was a multi­na­tional ran­domised dou­ble-blind con­trolled trial of 52 weeks on more than 500 pa­tients with rheuma­toid arthri­tis in 11 coun­tries. The study com­pared YLB113’s ef­fi­cacy and safety di­rectly against En­brel, the branded ver­sion of the bi­o­log­i­cal drug from in­no­va­tor Am­gen which has an es­ti­mated $11-bil­lion mar­ket.

The study was con­ducted at 110 rheuma­tol­ogy clin­ics across Japan, Europe and In­dia and in­cluded 260 Ja­panese pa­tients from 62 rheuma­tol­ogy clin­ics, a scale dis­tinct for a global RA trial in Japan. YLB is in the process of com­pil­ing a reg­u­la­tory dossier for sub­mis­sion to Ja­panese reg­u­la­tor PMDA for its mar­ket­ing au­tho­ri­sa­tion.

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