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Biosimilars of etanercept Posted 20/06/2014

Last update: 6 July 2018

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 [3]

BioXpress Therapeutics, Switzerland

BX2922

In pipeline [4]

Celltrion, South Korea

CT-P05

In pipeline

Cipla, India*

Etacept

'Similar biologic' launched in India in April 2013 [5]

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 [6]. Positive phase III results reported in June 2016

Hanwha Chemical, South Korea

Davictrel (HD203)

Davictrel approved by South Korean Ministry of Food and Drug Safety (MFDS) on 11 November 2014 [7]

Intas Pharmaceuticals, India*

Intacept

‘Similar biologic’ launched in India in March 2015 [8]

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

Eucept (LBEC0101)

Phase I trial completed [9]. Two phase III trials in rheumatoid arthritis ongoing. Approved in Japan in January 2018 [10]. Approved in South Korea in in March 2018 [11]

mAbxience, Spain

-

In pipeline

Momenta Pharmaceuticals, USA

-

Momenta was collaborating with Baxter on six biosimilars [12]. Collaboration ended in September 2016 [13]

Mycenax Biotech/TSH Biopharm Corp, Taiwan

TuNEX (ENIA11)

Carrying out phase III trials in Japan and South Korea [9]

Probiomed, Mexico*

Infinitam

Infinitam marketed in Mexico [14]

Protalix Biotherapeutics, Israel

PRX-106

In preclinical studies [9]

Sandoz, Switzerland

Erelzi (GP2015)

Phase III trial in psoriasis estimated to be completed in April 2015 [15]. Approved by US FDA on 30 August 2016 [16]. Positive results from phase III trial reported in November 2016 [17]. Approved by EC on 23 June 2017 [18]. Approved in Canada in August 2017 [19].Approved in Australia in November 2017 [20]

Samsung Bioepis (Biogen/Samsung)/Merck [21], South Korea/USA

Brenzys/Benepali (SB4)

Brenzys approved in South Korea on 8 September 2015 [22]. Benepali approved in EU on 14 January 2016 [23]. Brenzys approved in Australia in July 2016 [24] and in Canada in August 2016 [25]. Positive switching data reported in June 2017 [26]

Shanghai Celen, China

Qiangke

Markets ‘copy biologic’ Qiangke in China

Shanghai CP Guojian Pharmaceutical, China*

Etanar/Yisaipu

Markets 'copy biological' Yisaipu in China and ‘similar biotherapeutic product’ as Etanar in Colombia [24]

YL Biologics (Lupin/Yoshida [28]), India*/Japan

YLB113

Global phase III trials in rheumatoid arthritis completed in February 2018 [29]. Submitted for approval in Japan in March 2018 [10]. Submitted for approval by EMA in May 2018 [10]

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

*See editor’s comment

Cipla, Hanwha Chemical 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 [23]. The product was also approved in Australia [24] and in Canada [25], as Brenzys, where it will be marketed by Merck, in July and August 2016, respectively.

Sandoz announced in October 2015 that FDA had approved the application for its proposed etanercept biosimilar (GP2015) [16]. This was followed by EMA’s approval of its etanercept biosimilar application in April 2017 [18] and approval in Canada in August 2017 [19].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India, ‘copy biologics’ approved in China, ‘biogenerics’ approved in Iran, ‘biocomparables’ approved in Mexico, and ‘similar biotherapeutic products’ approved in Colombia might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The 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.

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References
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22.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar etanercept approved in South Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-South-Korea
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29.  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 6]. Available from: www.gabionline.net/Biosimilars/Research/Yoshindo-and-Lupin-s-etanercept-biosimilar-completes-trials 

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Source: ClinicalTrials.gov, EMA

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