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Lupin on Friday said that its Marketing Authorisation Application for a biosimilar of Etanercept has been accepted for review by the European Medicines Agency.
The indications targeted for approval are rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. This follows an application that was made to Japan’ Pharmaceuticals and Medical Devices Agency (PMDA) in March, the company said in a note to the bourses.
This filing opens up other key markets such as Canada, Australia, the Middle East, South East Asia and Latin America. The approvals for these markets are expected within the next 12 to 18 months. Shares of Lupin edged up 0.44 per cent at ₹745.60 on the NSE.
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