Lupin Files for Regulatory Approval of Etanercept Biosimilar in Europe

Drug maker Lupin announced last week that its marketing authorization application for a proposed etanercept biosimilar, YLB113, was accepted by the European Medicines Agency (EMA).

“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, in a statement.

The filing in Europe follows a new drug application for the biosimilar submitted to Japan’s Pharmaceuticals and Medical Devices Agency in March for all indications of the reference product, including adult rheumatoid arthritis (RA) and juvenile idiopathic arthritis.

Earlier this year, Lupin and its partner, Yoshindo Inc., announced the positive results of a global phase 3 clinical trial of the potential etanercept biosimilar. The multinational, randomized, 52-week double-blind controlled trial included more than 500 patients with RA in 11 countries and compared the efficacy of the proposed biosimilar directly with the reference product, Enbrel.

The study met its primary endpoint of equivalent improvement in RA, as measured by the American College of Rheumatology’s criteria for 20% improvement (ACR20). Importantly, the safety and immunogenicity of YLB113 were also similar to those of the reference product.

“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,” said Cyrus Karkaria, MD, president of biotechnology at Lupin, in a statement. “This is a significant step to fight against severe auto-immune disorders that call for an effective, affordable equivalent for patients across Europe.”

Lupin has also indicated that it is on track with a plan to file the proposed etanercept biosimilar for FDA regulatory approval in the third quarter of the 2020 fiscal year.