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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Pivotal clinical trials for adalimumab biosimilars
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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