Earlier this month, Lupin filed NDA for Etanercept in Japan through its subsidiary and a JV. Etanercept is the first biosimilar developed by Lupin in-house and It is also a first Indian company to file Etanercept in regulated markets. Biocon is still in early stages of development in Etanercept.
Company has said that this filing also opens up other key markets like Canada, Australia, Middle East, South East Asia and Latin America, where it expects approvals within the next 12-18 months.
The ex-US market for Etanercept is estimated at $4bn in Japan, Europe, other regulated and emerging markets. Lupin is also planning to file Etanercept biosimilar in the US market in FY19-20E.