EMA approval for adalimumab biosimilars Amgevita and Solymbic

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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that it had recommended granting of marketing authorization for the adalimumab biosimilars Amgevita and Solymbic.

Rheumatology RCPI V13C29

The adalimumab biosimilars, Amgevita and Solymbic (ABP 501), are produced by biotech giant Amgen. The drugs are biosimilars of AbbVie’s Humira (adalimumab), a tumour necrosis factor (TNF) inhibitor, which is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

EMA’s CHMP has recommended that Amgevita be approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis.  While for Solymbic the recommendation includes rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis.

The Marketing Authorization Application (MAA) submission for ABP 501 was based on a comprehensive data package supporting biosimilarity to adalimumab based on 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 ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 were also included in the submission.

The two TNF inhibitors mark Amgen’s first biosimilar approvals in Europe and are also the first biosimilars to receive a positive opinion from EMA’s CHMP in 2017. Although, according to EMA’s December 2016 list of biosimilars application, the agency was reviewing four adalimumab biosimilar applications, leaving two adalimumab biosimilars still under review [1].

The patents on Humira are only expected to expire in Europe in October 2018 [2], perhaps presenting a barrier to the adalimumab biosimilars hitting the market in Europe.

The CHMP’s opinion will now be reviewed by the European Commission.  If approved, Amgevita and Solymbic would be the first adalimumab biosimilars to be approved in Europe. Amgen received US Food and Drug Administration approval for ABP 501, called Amjevita (adalimumab-atto) in the US, in September 2016 [3].

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA – December 2016 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-applications-under-review-by-EMA-December-2016
2. GaBI Online - Generics and Biosimilars Initiative. Biologicals patent expiries [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from: www.gabionline.net/Biosimilars/General/Biologicals-patent-expiries
3. GaBI Online - Generics and Biosimilars Initiative. FDA approval for Amgen’s adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 10]. Available from: www.gabionline.net/Biosimilars/News/FDA-approval-for-Amgen-s-adalimumab-biosimilar

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Source: Amgen, EMA

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