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Phase III study of biosimilar adalimumab meets primary endpoint Posted 10/10/2014

Biologicals major Amgen announced on 8 October 2014 the first late-stage data from its biosimilars programme. Primary efficacy analysis from a phase III trial of Amgen’s adalimumab biosimilar (ABP 501) compared with Humira (adalimumab) has demonstrated ‘clinical equivalence’.

AbbVie’s blockbuster autoimmune disease treatment 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.

According to ClinicalTrials.gov, Amgen’s 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 still ongoing, planned to enrol 350 patients aged 18 years and above across 52 sites in Australia, Canada, France, Germany, Hungary, and Poland. Patients were randomized to receive a solution of ABP 215 or Humira by subcutaneous injection with an initial dose of 80 mg in Week 1, followed by 40 mg at Week 2 and every 2 weeks thereafter until Week 52. The trial is expected to be completed in March 2015.

The primary efficacy endpoint of per cent improvement in PASI after 16 weeks of treatment was within the pre-specified equivalence margin for ABP 501 compared to Humira. The safety and immunogenicity of ABP 501 were also found to be comparable to Humira.

Amgen also has a phase III trial underway to study the safety and efficacy of ABP 501 versus Humira in subjects with rheumatoid arthritis [1]. Amgen intends to use the results of these two phase III studies to form the basis for global regulatory submissions for ABP 501.

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].

Amgen has six biosimilars in development and expects to start launching products in 2017.

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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 Oct 10]. 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 Oct 10]. 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 Oct 10]. 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 Oct 10]. Available from: www.gabionline.net/Biosimilars/News/Sandoz-starts-phase-III-biosimilar-adalimumab-trial

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Source: Amgen

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