Biosimilar adalimumab application submitted to EMA

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Biosimilar adalimumab application submitted to EMA

Biosimilars/News | Posted 11/12/2015 0 Post your comment

Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).

Amgen believes the submission to be the first adalimumab biosimilar application submitted to EMA and says that it also represents the company’s first biosimilar to be submitted for approval in the European Union.

The news follows Amgen’s submission of its biosimilar adalimumab application in the US [1].

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 [2].

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 [3]. The phase III studies met their primary endpoints, which Amgen claims shows ‘clinical equivalence to adalimumab’ [4]. 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.

Biosimilars of adalimumab

References
1. GaBI Online - Generics and Biosimilars Initiative. Amgen submits biosimilar adalimumab application to FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Amgen-submits-biosimilar-adalimumab-application-to-FDA
2. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
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 Dec 11]. Available from: www.gabionline.net/Biosimilars/News/Amgen-starts-another-phase-III-trial-for-biosimilar-adalimumab
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for Amgen adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Dec 11]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-Amgen-adalimumab-biosimilar

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Source: Amgen