Lupin submits marketing authorization application for Etanercept biosimilar

Lupin’s marketing authorization application (MAA) for a biosimilar of Etanercept has been accepted for review by the European Medicines Agency (EMA). 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 Etanercept biosimilar and its acceptance in Europe is a significant milestone for the foray into biosimilars in key developed markets.

Earlier this month, Lupin filed the NDA in Japan through YL Biologics (YLB), 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. It compared YLB113’s efficacy and safety directly against Enbrel (of Amgen/Pfizer). The study was conducted at 110 rheumatology clinics across Japan, Europe, and India.

Etanercept (YLB113) is the first biosimilar developed in-house by Lupin and this makes them 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. Lupin has made significant investments in the biosimilars space over the last decade, and this application is an important achievement for the company’s journey for future developments in biologics.

This filing also opens other key markets like Canada, Australia, the Middle East, South East Asia, and Latin America. The approvals for these markets are expected within the next 12–18 months. Lupin is on course with its plans for biosimilar Etanercept filing in the United States of America and is targeting the same in FY 2019-20.