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Biosimilars of etanercept Posted 20/06/2014

Last update: 9 December 2016

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$8.3 billion in 2014, 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

Avesthagen, India*

Avent

Patented in India in 2010. In preclinical studies as of 2012 [3]

BioXpress Therapeutics, Switzerland

BX2922

Biosimilar in pipeline [4]

Cipla, India*

Etacept

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

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]

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, South Korea

LBEC0101

Phase I completed [9]

Momenta Pharmaceuticals, USA

-

Momenta was collaborating with Baxter on six biosimilars [10]. Collaboration ended in September 2016 [11]

Mycenax Biotech/TSH Biopharm Corp, Taiwan

TuNEX (ENIA11)

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

Protalix Biotherapeutics, Israel

PRX-106

In preclinical studies [9]

Sandoz, Switzerland

GP2015

Phase III study in psoriasis estimated to be completed in April 2015 [12]. Submitted to US FDA for approval on 2 October 2015 [13]. and to EMA on 8 December 2015 [14]. Recommended for approval by FDA’s Arthritis Advisory Committee on 13 July 2016 [15]. Positive results from phase III study reported in November 2016 [16]

Samsung Bioepis/Merck [17], South Korea/USA

Brenzys/Benepali (SB4)

Brenzys approved in Korea on 8 September 2015 [18]. Benepali approved in EU on 14 January 2016 [19]. Brenzys approved in Australia in July 2016 [20] and Canada in August 2016 [21]

Shanghai CP Guojian Pharmaceutical, China*

Etanar/Yisaipu

Markets 'copy biological' Yisaipu in China and ‘similar biotherapeutic product’ as Etanar in Colombia [22]

EU: European Union.

*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 Benepali (SB4), from Samsung Bioepis (Samsung and Biogen’s joint venture) was approved in the European Union on 14 January 2016 [19] The product was also approved in Australia [20] and in Canada [21], as Brenzys, where it will be marketed by Merck, in July and August 2016, respectively.

Sandoz announced in October 2015 that FDA had accepted its application for its proposed etanercept biosimilar [13]. This was followed in December 2015 by news that Sandoz’s biosimilar etanercept application had also been accepted by the EMA [14]. Then in July 2016 GP2015 was recommended for approval by the FDA’s Arthritis Advisory Committee [15].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India, copy biologics’ approved in China 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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