Japanese approval for Lupin’s etanercept biosimilar

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Japanese approval for Lupin’s etanercept biosimilar

Biosimilares/Novedades | Posted 01/04/2019 0 Post your comment

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.

YL Biologics is a joint venture for biosimilars made between Lupin’s subsidiary Lupin Atlantis Holdings and Japanese generics maker Yoshindo back in April 2014 [1]. YL Biologics submitted the application for approval of YLB113 in Japan back in March 2018 [2].

The submission followed the successful completion of a global phase III trial in February 2018. The multi-country, randomized, double-blind, controlled trial measured the efficacy and safety of YLB113 compared with originator etanercept Enbrel in more than 500 patients with rheumatoid arthritis across 11 countries. The study was conducted at 110 rheumatology clinics across Japan, Europe and India. Notably, it included more than 260 Japanese patients from 62 rheumatology clinics [3]. Data from this study was used in the submission package.

The PMDA has approved the etanercept biosimilar (YLB113) from Lupin and YL Biologics for the treatment of moderate to severe rheumatoid arthritis and juvenile idiopathic arthritis.

There is already one etanercept biosimilar approved in Japan. The PMDA approved Japan-based Mochida Pharmaceutical’s Etanercept BS [etanercept biosimilar 1] in January 2018 [4].

Lupin also announced in May 2018 that its candidate etanercept biosimilar (YLB113) had been accepted for regulatory review by the European Medicines Agency [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Lupin and Yoshindo start biosimilars joint venture [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture
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 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/News/Etanercept-biosimilars-submitted-to-EMA-and-launched-in-Japan
3. GaBI Online - Generics and Biosimilars Initiative. Yoshindo and Lupin’s etanercept biosimilar completes trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/Research/Yoshindo-and-Lupin-s-etanercept-biosimilar-completes-trials
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 1]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan

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Source: Lupin