Mylan and Lupin make deal for etanercept biosimilar

INICIO/Noticias Farmacéuticas | Posted 20/07/2018 post-comment0 Post your comment

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) and US-based drugmaker Mylan announced on 28 June 2018 that they had made a deal to commercialize an etanercept biosimilar.

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As part of the agreement, Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. Lupin will receive an up-front payment of US$15 million and potential commercial milestones together with an equal share in net profits of the product.

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. It is indicated for the treatment of rheumatoid, juvenile rheumatoid and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Lupin successfully completed a phase III clinical trial for its candidate etanercept biosimilar (YLB113) in February 2018 [1]. The company had the application for YLB113 accepted for regulatory review by the European Medicines Agency in May 2018 [2]. The company also announced in May 2018 that YL Biologics had submitted a new drug application (NDA) in Japan for YLB113 in March 2018 [2]. YL Biologics is a joint venture between Lupin and Japanese firm Yoshindo [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Yoshindo and Lupin’s etanercept biosimilar completes trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 20]. Available from: www.gabionline.net/Biosimilars/Research/Yoshindo-and-Lupin-s-etanercept-biosimilar-completes-trials
2. GaBI Online - Generics and Biosimilars Initiative. Etanercept biosimilars submitted to EMA and launched in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 20]. Available from: www.gabionline.net/Biosimilars/News/Etanercept-biosimilars-submitted-to-EMA-and-launched-in-Japan
3. GaBI Online - Generics and Biosimilars Initiative. Lupin and Yoshindo start biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 20]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture

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Source: Mylan

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