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Lupin’s arm’s JV submits New Drug Application for Etanercept biosimilar in Japan

08 May 2018 Evaluate

Lupin’s Japanese subsidiary Kyowa’s Joint Venture (JV) -- YL Biologics (YLB) -- has submitted a New Drug Application (NDA) for Marketing Authorization to the Pharmaceuticals and Medical Devices Agency (PMDA) for a biosimilar of Etanercept to treat indications for moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis.

YL Biologics and Kyowa filed the NDA in Japan in March, 2018.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.


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