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Amgen starts another phase III trial for biosimilar adalimumab Posted 14/03/2014

US biotechnology giant Amgen has started recruiting for a phase III clinical trial of its biosimilar adalimumab in patients suffering from plaque psoriasis, according to the US clinical trials website, Clinicaltrials.gov.

Amgen’s drug is a biosimilar version of AbbVie’s blockbuster autoimmune disease treatment Humira (adalimumab). Humira is a tumour necrosis factor (TNF) inhibitor that is approved to treat rheumatoid, juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Amgen already has a phase III trial underway to study the safety and efficacy Amgen’s biosimilar (ABP 501) versus AbbVie’s Humira in subjects with rheumatoid arthritis [1]. This second phase III study will compare the effectiveness and safety of ABP 501 and Humira in adults with plaque psoriasis.

The trial is a multicentre, double-blind, randomized, active-controlled, parallel-group study. The main objective of the study is to compare the effectiveness of ABP 501 and Humira in subjects with moderate to severe plaque psoriasis with respect to the per cent improvement in Psoriasis Area and Severity Index (PASI) after treatment.

The trial, which is now reported to be recruiting patients, will be conducted in Australia, Canada, France, Germany, Hungary and Poland, and will include 340 patients, aged 18–75 years.

Sales for Humira, the world’s top-selling prescription drug, were almost US$10.7 billion in 2013, accounting for almost 60% of AbbVie’s total sales. The patents on Humira expire in the European Union in 2016 and in the US in 2018 [2].

Amgen is not the only pharma company with its sights set on adalimumab. Pharma giant Pfizer has also started phase I study for its biosimilar adalimumab candidate (PF-06410293) [3]. While generics giant Sandoz started a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from psoriasis in December 2013 [4].

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References

1.   GaBI Online - Generics and Biosimilars Initiative. Amgen to start phase III trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 14]. Available from: www.gabionline.net/Biosimilars/News/Amgen-to-start-phase-III-trial-for-biosimilar-adalimumab

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 2014 Mar 14]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

3.   GaBI Online - Generics and Biosimilars Initiative. Pfizer to start trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 14]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-to-start-trial-for-biosimilar-adalimumab

4.   GaBI Online - Generics and Biosimilars Initiative. Sandoz starts phase III biosimilar adalimumab trial [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 14]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-starts-phase-III-biosimilar-adalimumab-trial

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Source: Clinicaltrials.gov

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