Lupin submits Marketing Authorization Application for Etanercept Biosimilar in Europe

Lupin is a first Indian company to file Etanercept in regulated markets.

May 25, 2018 01:05 IST India Infoline News Service

Lupin has announced that its Marketing Authorization Application (MAA) for Etanercept biosimilar has been accepted for review by the European Medicines Agency (EMA). Etanercept (brand Enbrel) is indicated for treatment in Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis, Axial spondyloarthritis, Non-radiographic axial spondyloarthritis and Plaque Psoriasis. This is a significant milestone for Lupin as it aims to foray into biosimilars markets in developed countries.

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.

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