May 8: Mumbai-based pharma major Lupin Ltd on Tuesday announced that YL Biologics (YLB) – its JV with Yoshindo and Kyowa (Lupin’s Subsidiary) in Japan has submitted a New Drug Application (NDA) for marketing authorization to the Pharmaceuticals and Medical Devices Agency (PMDA) for a biosimilar of Etanercept (YLB113).
According to the company, the product is to treat indications for moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis. YL Biologics and Kyowa filed the NDA in Japan in March, 2018, it said.
“The application for Etanercept biosimilar is a significant milestone for Lupin as we build our biosimilars pipeline. With the application now filed, we are preparing to launch an affordable and high-quality biosimilar for consumers in Japan. This is an encouraging outcome as we make a strategic shift across Lupin to higher complexity products,” said Nilesh Gupta, Managing Director, Lupin.
In February this year, YL Biologics announced the successful conclusion of its global Phase III study of biosimilar of Etanercept (YLB113).
According to Dr. Toshihiko Hibino, President of YLB, “this application marks the first biosimilar developed as part of the JV between Lupin and Yoshindo. We are excited by the development which is a complex fusion protein for a regulated market like Japan, and will help make the product accessible to the patients.”
This filing also opens up other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America for this product. The approvals for these markets are expected within the next 12 to 18 months timeframe.