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Biosimilars of etanercept Posted 20/06/2014

Last update: 20 November 2020 

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.

The originator product, Amgen/Pfizer’s Enbrel (etanercept), was approved by the US Food and Drug Administration (FDA) in November 1998 and by the European Medicines Agency (EMA) in February 2000 [1]. Enbrel had sales of US$8.87 billion in 2015, before the advent of biosimilars, making it one of the top selling biologicals and a lucrative target for biosimilars developers, see Table 1.

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 [1, 2].  Some of the etanercept biosimilars and non-originator biologicals* approved or in development are presented in Table 1.

Table 1: Biosimilars and non-originator biologicals* of etanercept approved or in development

Company name, Country

Product name

Stage of development

AryoGen Pharmed, Iran*

Altebrel

Approved by Iran’s FDO

Avesthagen, India*

Avent

Patented in India in 2010. In preclinical studies as of 2012

BioXpress Therapeutics, Switzerland

BX2922

In pipeline 

Celltrion, South Korea

CT-P05

In pipeline

Cipla, India*

Etacept

'Similar biologic' launched in India in April 2013 [3]

Clover Biopharmaceuticals, China*

SCB-808

Phase I

Coherus BioSciences/Baxalta (part of Shire), USA

CHS-0214/BAX 2200

Global phase III trials in psoriasis and rheumatoid arthritis expected to be completed in July and October 2015. Positive phase III results reported in June 2016.

Hanwha Chemical, South Korea

Davictrel (HD203)

Davictrel approved by South Korean MFDS on 11 November 2014 [4]

Hisun Pharmaceuticals, China*

AnBaiNuo

Markets 'copy biological' AnBaiNuo in China since 2015

Intas Pharmaceuticals, India*

Intacept

‘Similar biologic’ launched in India in March 2015 [3]

LG Life Sciences (LG Chem)/ Mochida Pharmaceutical, South Korea/Japan

Eucept (LBEC0101)

Approved in Japan in January 2018 [5] and in South Korea in March 2018 [6]

mAbxience, Spain

-

In pipeline

Momenta Pharmaceuticals, USA

-

Momenta was collaborating with Baxter on six biosimilars. Collaboration ended in September 2016

Mycenax Biotech/TSH Biopharm Corp, Taiwan

TuNEX (ENIA11)

Carrying out phase III trials in Japan and South Korea

Nanogen, Vietnam*

Nanercept

Follow-on biological product' marketed in Vietnam

Probiomed, Mexico*

Infinitam

Infinitam marketed in Mexico [7]

Protalix Biotherapeutics, Israel

PRX-106

Preclinical 

Sandoz, Switzerland

Erelzi (GP2015)

Approved by FDA in August 2016 [8], by EC in June 2017 [9], in Canada in August 2017 [10] and in Australia in November 2017 [11]

Samsung Bioepis (Biogen/Samsung)/ Merck, South Korea/USA

Brenzys/Benepali/ Eticovo (SB4)

Brenzys approved in South Korea in September 2015 [6]. Benepali approved in EC in January 2016 [9]. Brenzys approved in Australia in July 2016 [11] and in Canada in August 2016 [10]. Eticovo approved by FDA in April 2019 [8]. Brenzys (Merck Canada) indications expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis [12].

Shanghai Celgen Biopharma, China*

Qiangke

Markets ‘copy biologic’ Qiangke in China since 2011 [13]

Shanghai CP Guojian Pharmaceutical, China*

Etanar/Yisaipu

Markets 'copy biological' Yisaipu in China since 2005 [13] and ‘similar biotherapeutic product’ as Etanar in Colombia [7]

YL Biologics (Lupin/Yoshida), India*/ Japan; Mylan/Lupin, USA/India*

Nepexto (YLB113)

Approved in Japan in March 2019 [14] and by EC in May 2020 [15]

EMA: European Medicines Agency; EU: European Union; FDA: US Food and Drug Administration; FDO: Food and Drug Organization (Iran’s National Regulatory Authority); MFDS: Ministry of Food and Drug Safety.

*See editor’s comment

Cipla, Hanwha Chemical, Hisun Pharmaceuticals and Shanghai CP Guojian Pharmaceutical all have non-originator biological versions of etanercept already in the market. The etanercept biosimilar Benepli (SB4), from Samsung Bioepis (Samsung and Biogen’s joint venture) was approved in the European Union (EU) on 14 January 2016. The product was also approved in Australia in July 2016, in the US in April 2019 as Eticovo, and in Canada in August 2016 as Brenzys, where it will be marketed by Merck, and the indications of Merck Canada’s etanercept biosimilar Brenzys have been expanded to include plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis [12].

Sandoz announced in October 2015 that FDA had approved the application for its proposed etanercept biosimilar (GP2015) [8]. This was followed by European approval of its etanercept biosimilar application in April 2017 and approval in Canada in August 2017.

The etanercept biosimilar Nepexto (YLB113) by YL Biologics was approved in Japan in March 2019 [14]; whilst the same by Merck Mylan/Lupin was approved by EC in May 2020 [15].

Editor’s comment
European Medicines Agency regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that ‘medicamento biológico similares’ approved in Argentina, ‘copy biologicals’ approved in China, ‘similar biotherapeutic products’ approved in Colombia, ‘similar biologics’ approved in India, ‘biogenerics’ approved in Iran, ‘biocomparables’ approved in Mexico, and ‘follow-on biological products’ approved in Vietnam might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. 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 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028 
3. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India 
4. GaBI Online - Generics and Biosimilars Initiative. Hanwha to transfer biosimilar etanercept technology to Merck [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 20]. Available from: www.gabionline.net/Biosimilars/News/Hanwha-to-transfer-biosimilar-etanercept-technology-to-Merck 
5. 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 6]. Available from: www.gabionline.net/Biosimilars/News/Etanercept-biosimilars-submitted-to-EMA-and-launched-in-Japan 
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea 
7. GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America 
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
9. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe 
10. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Canada [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Canada
11. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jul 6]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia 
12. GaBI Online - Generics and Biosimilars Initiative. Indications expanded for Merck’s etanercept biosimilar Brenzys [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/Indications-expanded-for-Merck-s-etanercept-biosimilar-Brenzys 
13. GaBI Online - Generics and Biosimilars Initiative. Copy biologicals approved in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/General/Copy-biologicals-approved-in-China 
14. GaBI Online - Generics and Biosimilars Initiative. Japanese approval for etanercept biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/Japanese-approval-for-Lupin-s-etanercept-biosimilar 
15. GaBI Online - Generics and Biosimilars Initiative. EC approval for etanercept biosimilar Nepexto [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Nov 20]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-etanercept-biosimilar-Nepexto 

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Source: ClinicalTrials.gov, EMA

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