Biosimilars of AbbVie’s Humira (adalimumab), a human monoclonal antibody, are currently under development.
Adalimumab treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. It binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases, such as rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
Pivotal trials for candidate adalimumab 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 adalimumab biosimilars
| Study ID
|
Product name
|
Company name, country
|
Phase
|
Trial design
|
Status
|
No. of subjects
|
Start/end dates
|
Primary outcome(s)
|
| Psoriasis
|
| NCT01970488
|
ABP 501
|
Amgen, USA
|
III
|
Parallel assignment with partial crossover (Humira responders re-randomized)
|
Completed
|
350
|
Oct 2013/ Mar 2015
|
PASI % improvement
|
| 2013-000537-12
|
ABP 501
|
Amgen, USA
|
III
|
2-arm, parallel
|
Ongoing
|
350
|
Sep 2013/-
|
PASI % improvement
|
| NCT02016105
|
GP2017
|
Sandoz, Switzerland
|
III
|
2-arm, parallel
|
Ongoing
|
448
|
Dec 2013/ Apr 2016
|
PASI75
|
| Rheumatoid arthritis
|
| NCT01970475
|
ABP 501
|
Amgen, USA
|
III
|
2-arm, parallel
|
Completed
|
526
|
Oct 2013/ Nov 2014
|
ACR20
|
| 2013-004654-13
|
ABP 501
|
Amgen, USA
|
III
|
1-arm (extension study)
|
Ongoing
|
425
|
Feb 2014/-
|
AEs, SAEs, ACR20
|
| 2013-000525-31
|
ABP 501
|
Amgen, USA
|
III
|
2-arm, parallel
|
Completed
|
500
|
Aug 2013/ Nov 2014
|
ACR20
|
| NCT02137226
|
BI 695501
|
Boehringer Ingelheim, Germany
|
III
|
2-arm, parallel
|
Recruiting
|
650
|
Jan 2015/ Dec 2016
|
ACR20
|
| 2012-002945-40
|
BI 695501
|
Boehringer Ingelheim, Germany
|
III
|
2-arm, parallel
|
Ongoing
|
600
|
Sep 2014/-
|
DAS28
|
| 2014-000352-29
|
PF-06410293
|
Pfizer, USA
|
III
|
2-arm, parallel
|
Ongoing
|
560
|
Oct 2014/-
|
ACR20
|
| 2013-005013-13
|
SB5
|
Samsung Bioepis, South Korea
|
III
|
2-arm, parallel
|
Ongoing
|
490
|
Apr 2014/-
|
ACR20
|
| NCT02167139
|
SB5
|
Samsung Bioepis, South Korea
|
III
|
2-arm, parallel
|
Completed
|
490
|
May 2014/ May 2015
|
ACR20
|
| AE: adverse event; ACR20: 20% improvement in ACR (American College of Rheumatology) core set measurements; DAS28: Disease Activity Score for 28 joints; PASI: Psoriasis Area and Severity Index; PASI75: 75% or greater improvement in PASI score; SAE: serious adverse event.
|
The originator product, AbbVie’s Humira (adalimumab), was approved by the US Food and Drug Administration in December 2002 and by the European Medicines Agency in September 2003. The patents on Humira expire in the US in December 2016 and in Europe in April 2018 [2]. Humira had worldwide sales of almost US$12.5 billion in 2014.
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Pivotal clinical trials for infliximab biosimilars
Pivotal clinical trials for etanercept 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 Aug 28]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
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