23 May 2018 - Pharma major Lupin announced today that its marketing authorization application for a biosimilar of etanercept has been accepted for review by the EMA. 

The indications targeted for approval are rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. This follows an application that was made to Japan’s Pharmaceuticals and Medical Devices Agency in March this year.

Earlier this month, Lupin announced the filing of the NDA in Japan through YL Biologics, the joint venture of Lupin Limited and Yoshindo along with an additional filing from Kyowa, Lupin’s Subsidiary in Japan. YL Biologics had also announced the successful conclusion of its global Phase III study of biosimilar of etanercept (YLB113) in February 2018. The first-of-its-kind study was a multinational randomised double-blind controlled trial of 52 weeks duration, which included more than 500 patients with rheumatoid arthritis in 11 countries. It compared YLB113’s efficacy and safety directly against Enbrel (Amgen/Pfizer). The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 230 patients from Europe.

Read Lupin Pharmaceuticals press release