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Mylan and Lupin make deal for etanercept biosimilar Posted 20/07/2018

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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.

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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