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Lupin submits Application for Marketing Authorization for Enbrel biosimilar in Japan

This application marks the first biosimilar developed as part of the JV between Lupin and Yoshindo.

Lupin has said that it has filed new drug application for Marketing Authorization to Etanercept biosimilar in Japan. Lupin has a JV with Yoshindo in Japan, which is named as YL Biologics. Lupin’s subsidiary in Japan, Kyowa, in partnership with YL Biologics has filed for Etanercept biosimilar.

This application marks the first biosimilar developed as part of the JV between Lupin and Yoshindo. The Biologics market in Japan is expected to reach $13.5bn in 2019. The current healthcare spends on biologic drugs is ~14%, which is also expected to rise in the coming years.

Etanercept is used to treat autoimmune disorders like moderate to severe Rheumatoid Arthritis and Juvenile Idiopathic Arthritis. This is the first biosimilar for regulated markets developed in-house at Lupin and is a significant milestone for Lupin.

Lupin, over the next 12-18 months, expects to file Enbrel biosimilar in other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America. The market for Enbrel biosimilar in ex-US countries is pegged to be ~$4bn. Lupin is also targeting to file Enbrel in the US in FY 2019-20.

We believe that this is the first Enbrel biosimilar filings in the Japanese market.

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