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Pivotal clinical trials for etanercept biosimilars

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Biosimilars of Amgen/Pfizer’s blockbuster arthritis drug Enbrel (etanercept), a fusion protein produced by recombinant DNA, are currently under development.

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

Pivotal trials for candidate etanercept biosimilars being carried out typically include one in rheumatoid arthritis and one in psoriasis, each including around 500 patients and taking less than two years [1], see Table 1.

Table 1: Pivotal clinical trials for candidate etanercept biosimilars

Study ID	Product name	Company name, country	Phase	Trial design	Status	No. of subjects	Start/end dates	Primary outcome(s)
Psoriasis
2014-000444-14	CHS-0214	Coherus Biosciences, USA	III	2-arm, parallel	Ongoing	424	Jan 2015/-	PASI % improvement, PASI75
NCT02134210	CHS-0214	Coherus Biosciences, USA	III	2-arm, parallel	Ongoing	496	Jun 2014/ May 2016	PASI75
NCT02486939 (also in rheumatoid arthritis patients)	CHS-0214	Coherus Biosciences, USA	III	1-arm (extension study)	Not yet recruiting	400	Jul 2015/ Apr 2017	AE, Labs, Vital signs, Physical examinations, Immunogenicity
2012-002011-26	GP2015	Sandoz, Switzerland	III	2-arm, parallel	Completed	546	May 2013/ Mar 2015	PASI75
NCT01891864	GP2015	Sandoz, Switzerland	III	2-arm, parallel	Completed	531	Jun 2013/ Mar 2015	PASI75
Rheumatoid arthritis
2014-000443-33/NCT02115750	CHS-0214	Coherus Biosciences, USA	III	2-arm, parallel	Ongoing	620	May 2014/ May 2016	ACR20
NCT02486939 (also in psoriasis patients)	CHS-0214	Coherus Biosciences, USA	III	1-arm (extension study)	Not yet recruiting	400	Jul 2015/ Apr 2017	AE, Labs, Vital signs, Physical examinations, Immunogenicity
NCT01270997	HD203	Hanwha Chemical, South Korea	III	2-arm, parallel	Completed	294	Dec 2010/ May 2012	ACR20
2012-005026-30	SB4	Samsung Bioepis, South Korea	III	2-arm, parallel	Ongoing	498	Aug 2013/ -	ACR20
ACR20: 20% improvement in ACR (American College of Rheumatology) core set measurements; AE: adverse event; DAS28: Disease Activity Score for 28 joints; Labs: Clinically significant changes in laboratory values and vital signs; PASI: Psoriasis Area and Severity Index; PASI75: 75% or greater improvement in PASI score.

The originator product, Amgen/Pfizer’s Enbrel (etanercept), was approved by the US Food and Drug Administration in November 1998 and by the European Medicines Agency in February 2000. The patents on Enbrel expire in the US in November 2028, after Amgen was granted a new patent, and in Europe in August 2015 [2, 3], Enbrel had sales of US$8.6 billion in 2014.

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Clinical programmes for anti-TNF biosimilars

References
1. Gal R. Biosimilars: at the inflection point. 13th EGA-European Biosimilars Group Conference; 23–24 April 2015; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Sep 4]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
3. 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 Sep 4]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028

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