Etanercept biosimilars submitted to EMA and launched in Japan Posted 15/06/2018

An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.

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

On 30 May 2018, Japan-based companies Mochida Pharmaceutical (Mochida) and AYUMI Pharmaceutical (AYUMI) announced the launch of the first etanercept biosimilar in Japan. Mochida developed Etanercept BS (LBEC0101) based on a collaboration agreement with South Korean-based LG Chem and AYUMI distributes the product in Japan. The biosimilar was approved in Japan in January 2018.

Mochida has also made a deal with LG Life Sciences to co-develop and commercialize an adalimumab biosimilar (LBAL) for the Japanese market [1]. 

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 25 May 2018 that its candidate etanercept biosimilar (YLB113) had been accepted for regulatory review by the European Medicines Agency (EMA). The company also announced on 8 May 2018 that YL Biologics had submitted a new drug application in Japan for YLB113 in March 2018.

The submissions follow the successful completion of a global phase III trial in February 2018. The trial measured the efficacy and safety of YLB113 compared with Enbrel in more than 500 patients with rheumatoid arthritis. Notably, it included more than 260 Japanese patients from 62 rheumatology clinics [2].

The Japanese submission was made by YL Biologics, which is a joint venture for biosimilars made between Lupin and Japanese generics maker Yoshindo back in April 2014 [3].

The application marks the first biosimilar developed as part of the joint venture between Lupin and Yoshindo. The companies expect the Japanese filing to open up other key markets. They intend to file in markets such as Australia, Canada, Europe, the Middle East, South East Asia and Latin America within the next 12 to 18 months.

Lupin is looking at complex generics, biosimilars and specialty medicines to be the main drivers of growth going forward. The company said in an investor presentation that its focus would be to deliver on key complex generics, especially inhalation and injectables, and to successfully file and commercialize biosimilars.

Both the etanercept products are proposed biosimilars to Amgen/Pfizer’s Enbrel (etanercept), which had worldwide sales of US$8.8 billion in 2015, before the advent of biosimilars. The patents on Enbrel will expire in the US in November 2028, after Amgen was granted a new patent, and expired in Europe in August 2015 [4, 5].

The biologicals market in Japan is expected to reach US$13.5 5 billion (JPY 1,480 billion) by 2019 and current healthcare spending on biologicals is around 14% by the government in Japan and this is expected to rise in the coming years.

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Biosimilars of etanercept

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Lupin and Neuclone biosimilars agreement

References
1. GaBI Online - Generics and Biosimilars Initiative. LG Life Sciences and Mochida make deal for adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 15]. Available from: www.gabionline.net/Biosimilars/News/LG-Life-Sciences-and-Mochida-make-deal-for-adalimumab-biosimilar
2. 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 Jun 15]. Available from: www.gabionline.net/Biosimilars/Research/Yoshindo-and-Lupin-s-etanercept-biosimilar-completes-trials
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 Jun 15]. Available from: www.gabionline.net/Biosimilars/News/Lupin-and-Yoshindo-start-biosimilars-joint-venture
4. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
5. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 15]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028

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Source: Lupin, Mochida

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