Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.
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 (TNFα), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases.
The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use positive recommendation on 27 January 2017 [1].
Amgevita (ABP 501) has been approved for all the indications of the reference biological, AbbVie’s Humira (adalimumab), in the European Union (EU). These include treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis; psoriatic arthritis; severe active ankylosing spondylitis (AS); severe axial spondyloarthritis without radiographic evidence of AS; moderate-to-severe chronic plaque psoriasis; moderate-to-severe hidradenitis suppurativa; non-infectious intermediate, posterior and panuveitis; moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis. The EC also approved Amgevita for the treatment of certain paediatric inflammatory diseases, including moderate-to-severe Crohn's disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
The approval was based on ‘a comprehensive data package supporting biosimilarity to Humira’, according to Amgen. This included analytical, pharmacokinetic and clinical data, including results from two phase III studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The phase III studies each met their primary endpoint showing ‘no clinically meaningful differences’ to adalimumab. Safety and immunogenicity of Amgevita ‘were also comparable’ to Humira.
The approval marks Amgen’s first biosimilar approved in the EU and the first adalimumab biosimilar to be approved in Europe. Amgen received US Food and Drug Administration (FDA) approval for ABP 501, called Amjevita (adalimumab-atto) in the US, in September 2016 [2].
The patents on Humira are only expected to expire in Europe in October 2018 [2] perhaps presenting a barrier to adalimumab biosimilars hitting the market in Europe. Despite this, Amgen is not the only company with adalimumab in its sights. Boehringer Ingelheim submitted applications for approval of its adalimumab biosimilar to EMA and FDA in January 2017 [3]. While Coherus Biosciences, Momenta Pharmaceuticals and Sandoz have all reported positive phase III data [3-5].
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Biosimilars approved in Europe
References
1. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Amgevita and Solymbic [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Amgevita-and-Solymbic
2. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from: www.gabionline.net/Biosimilars/News/Boehringer-Ingelheim-submits-biosimilar-adalimumab-application-to-both-EMA-and-FDA
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase III results for adalimumab and trastuzumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-results-for-adalimumab-and-trastuzumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Mar 31]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-adalimumab
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