May 25: Pharma major Lupin Ltd on Friday announced that its Marketing Authorization Application (MAA) for a biosimilar of Etanercept has been accepted for review by the European Medicines Agency (EMA).
According to the company, the indications targeted for approval are Rheumatoid Arthritis (RA), 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 (PMDA) in March this year.
“The application for our Etanercept biosimilar and its acceptance in Europe is a significant milestone for our foray into biosimilars in key developed markets. This is also an encouraging development as we continue building our pipeline of higher complexity products,” said Nilesh Gupta, Managing Director of Lupin Ltd.
Earlier this month, Lupin announced the filing of the NDA in Japan through YL Biologics (YLB), the joint venture of Lupin 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.
“Etanercept (YLB113) is the first biosimilar developed in-house by Lupin and this makes us the first Indian pharmaceutical company to file for a complex fusion protein like Etanercept in regulated markets. This is a significant step in the fight against severe auto-immune disorders that calls for an effective, affordable equivalent for patients across Europe,” said Cyrus Karkaria, President – Biotechnology at Lupin.
Lupin shares closed trading at Rs 747, up 0.66% from the previous closing of Rs 742.10, on BSE today.