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Yoshindo and Lupin’s etanercept biosimilar completes trials

Biosimilars/Research | Posted 23/03/2018 0 Post your comment

YL Biologics announced on 7 February 2018 that the global phase III trials of its etanercept biosimilar have been a success. YL Biologics is a joint venture of India’s Lupin Ltd and Japanese firm Yoshindo that was first announced in 2014 [1]. The etanercept biosimilar has met a successful outcome for rheumatoid arthritis treatment and hopes to compete for a share of the originator Enbrel’s global market of US$11 billion.

The randomized clinical trial was conducted in 11 countries over a 52-week period and included over 500 patients. It included 260 Japanese patients from 62 rheumatology clinics and was the first global rheumatoid arthritis trial of such scale to be carried out in Japan. Here, the YLB113 biosimilar’s efficacy and safety was compared with that of Amgen and Pfizer’s Enbrel and were shown to be similar.

The two companies have stated that they plan to apply for regulatory approval in the EU, India and Japan, in 2019. They also hope to apply for approval in the US in the years following this. In addition, they noted that together they remain committed to advancing their biotech R & D capabilities so that more patients across the world can access affordable, high quality biosimilars.

The YLB113 biosimilar is not the first etanercept biosimilar developed. There are competing biosimilars already approved and available across the globe [2-7].

Switching failures with biosimilar etanercept

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 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture
2. GaBI Online - Generics and Biosimilars Initiative. Quebec adds biosimilar etanercept Erelzi to public drug plan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/General/Quebec-adds-biosimilar-etanercept-Erelzi-to-public-drug-plan
3. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
4. GaBI Online - Generics and Biosimilars Initiative. TGA approves three biosimilars but fewer generics in 2017 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Reports/TGA-approves-three-biosimilars-but-fewer-generics-in-2017
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
7. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Mar 23]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea

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