Amgen submits biosimilar adalimumab application to FDA

Biosimilars/News | Posted 27/11/2015 post-comment0 Post your comment

Biotech giant Amgen announced on 25 November 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration (FDA).

Application V15a16

This is Amgen’s first biosimilar application and the company believes this also to be the first biosimilar adalimumab application submitted to FDA.

Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases.

The originator product, AbbVie’s Humira (adalimumab) is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Humira had worldwide sales of almost US$12.5 billion in 2014. The patents on Humira expire in the US in December 2016 and in Europe in April 2018 [1].

Amgen’s submission includes analytical, clinical and pharmacokinetic data. Phase III comparative efficacy and safety studies were conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis [2]. The phase III studies met their primary endpoints, which Amgen claims shows ‘clinical equivalence to adalimumab’ [3]. Safety and immunogenicity of ABP 501 were also comparable to adalimumab, according to Amgen. Data to support the transition of adalimumab patients to ABP 501 are also included in the submission.

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1.   GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from:

2.   GaBI Online - Generics and Biosimilars Initiative. Amgen starts another phase III trial for biosimilar adalimumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Nov 27]. Available from:

3.   GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for Amgen adalimumab biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 27]. Available from:

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Source: Amgen

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