US biopharmaceutical giant Amgen announced on 3 February 2015 positive results from its phase III clinical trial for a biosimilar version of adalimumab in patients suffering from rheumatoid arthritis.
The Amgen study evaluated the safety and efficacy of the company’s biosimilar (ABP 501) versus AbbVie’s blockbuster autoimmune disease treatment Humira (adalimumab) in subjects with moderate to severe rheumatoid arthritis.
Humira is a monoclonal antibody 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.
The multicentre, double-blind, randomized, active controlled, parallel-group study was carried out in Argentina, Bulgaria, Canada, Czech Republic, Germany, Hungary, Mexico, Poland, Romania, Russia, Spain, UK and US [1]. The trial enrolled 526 patients; 264 patients received ABP 501 and 262 patients received adalimumab 40 mg subcutaneously every two weeks.
The primary endpoint compared the ACR20 measurements (20% or greater improvement in American College of Rheumatology core set measurements) at week 24. The ACR20 was within the pre-specified margin for ABP 501 compared to Humira, showing clinical equivalence. Safety and immunogenicity of ABP 501 were also comparable to Humira. Key secondary endpoint requirements including ACR50, ACR70 and DAS 28-CRP (Disease Activity Score for 28 joints - C reactive protein) were also met.
AbbVie’s sales for Humira in 2013 were US$10.7 billion, the patents on Humira expire in the US in December 2016 and in Europe in April 2018 [2].
This is not the only trial Amgen is carrying out for its biosimilar adalimumab candidate. The company is also carrying out a phase III clinical trial of its biosimilar adalimumab in patients suffering from plaque psoriasis [3].
Amgen is not the only company working on adalimumab biosimilars [4]. Pharma giant Pfizer has also started a phase I study for its biosimilar adalimumab candidate (PF-06410293) according to the US clinical trials website, ClinicalTrials.gov [5], and Coherus Biosciences has reported ‘comparable pharmacokinetics’ in a pivotal clinical study for its adalimumab biosimilar (CHS-1420) [6].
Amgen has nine biosimilar molecules in development and expects to launch five of these biosimilars between 2017 and 2019.
Related article
Amgen expands biosimilars programme
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 2015 Feb 20]. 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 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020
3. GaBI Online - Generics and Biosimilars Initiative. Amgen starts another phase III trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/News/Amgen-starts-another-phase-III-trial-for-biosimilar-adalimumab
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
5. GaBI Online - Generics and Biosimilars Initiative. Pfizer to start trial for biosimilar adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/News/Pfizer-to-start-trial-for-biosimilar-adalimumab
6. GaBI Online - Generics and Biosimilars Initiative. Adalimumab biosimilar has comparable pharmacokinetics to Humira [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Biosimilars/Research/Adalimumab-biosimilar-has-comparable-pharmacokinetics-to-Humira
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