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Pivotal clinical trials for adalimumab biosimilars Posted 28/08/2015

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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Comments (2)

Adalimumab/ Biosimilar/ India posted 31/08/2015 - by Sandeep

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

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

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