Pivotal clinical trials for adalimumab biosimilars

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Biosimilars of AbbVie’s Humira (adalimumab), a human monoclonal antibody, are currently under development.

Clinical Trials 2 V13K29

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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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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Posted 31/08/2015 by Sandeep
Adalimumab/ Biosimilar/ India

Zydus Cadila has alraedy launched a biosimilar for Adalimumab in India, though am not sure of their plans for ex-India markets.
http://www.reuters.com/article/2014/12/09/us-cadila-health-humira-india-idUSKBN0JN0X820141209

Posted 28/08/2015 by alanmappel@gmail.com
adalimumab biosimilars

Do any of these trials, or others not described, comparing Ada and a biosimilar w/ respect to radiologic progression?
Thanks

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