New Delhi: Drug firm Lupin today said its Japanese arm and YL Biologics have submitted a new drug application (NDA) with the Japanese health regulator PMDA for marketing authorisation of a biosimilar of Etanercept used for the treatment of rheumatoid arthritis.
Lupin said, YL Biologics, its JV with Yoshindo, and its Japanese arm Kyowa have submitted the NDA with the Japanese authority.
The authorisation for Etanercept biosimilar is to treat indications for moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis, Lupin said in a statement.
Lupin MD Nilesh Gupta said: “The application for Etanercept biosimilar is a significant milestone for Lupin as we build our biosimilars pipeline.” With the application now filed, the company is preparing to launch an affordable and high-quality biosimilar for consumers in Japan, he added.
“This is an encouraging outcome as we make a strategic shift across Lupin to higher complexity products,” Gupta said.
In February this year, YL Biologics announced the successful conclusion of its global Phase III study of biosimilar of Etanercept.
“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,” YLB President Toshihiko Hibino said.
The Biologics market in Japan is expected to reach USD 13.5 billion next year and the current healthcare spends on biologics is around 14 percent by the government in Japan and this is expected to rise in the coming years, he said.
“After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed in-house at Lupin and the first ever complex fusion protein like Etanercept in regulated markets by an Indian pharmaceutical player,” Lupin Biotech President Cyrus Karkaria said.
This filing also opens up other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America for this product, Lupin said.
The approvals for these markets are expected within the next 12 to 18 months timeframe, it added.
Shares of Lupin today closed at Rs 775.40 per scrip on BSE, up 0.10 percent from its previous close.