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Pivotal clinical trials for adalimumab biosimilars

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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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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