Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 3 May 2019 that it had launched its adalimumab biosimilar Idacio in Germany.
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. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.
Fresenius Kabi has made its first biosimilar available for sale in pre-filled syringe, pre-filled pen and vial presentations.
The launch in Germany follows the European Commission (EC) approval of Idacio for all the indications of the reference product (Humira) on 3 April 2019 [1]. This followed the European Medicines Agency’s (EMA) recommendation, which was based on a comprehensive data package that included a comparison of the pharmacokinetics, safety, and immunogenicity of the biosimilar in healthy volunteers, as well as a phase III study in patients with moderate to severe plaque psoriasis [2].
The company said the launch in Germany had come earlier than originally expected and that it ‘will launch the product over time thereafter in the various other EU Member States, pending the adoption from the respective national authorities.’ The company is following a customized market-by-market approach due to the heterogeneity of the European markets.
There are already nine other adalimumab biosimilars approved in Europe, including Amgevita, Cyltezo, Halimatoz, Hefiya, Hulio, Hyrimoz, Imraldi, Kromeya and Solymbic [3].
In the US, Fresenius Kabi has made a deal with AbbVie, which will mean that its adalimumab biosimilar, once approved, will only be able to launch from September 2023 [4].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approval for adalimumab biosimilar Idacio [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-adalimumab-biosimilar-Idacio
2. GaBI Online - Generics and Biosimilars Initiative. EMA approval for adalimumab biosimilars Idacio and Kromeya [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Idacio-and-Kromeya
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. AbbVie makes more deals delaying adalimumab biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 May 17]. Available from: www.gabionline.net/Pharma-News/AbbVie-makes-more-deals-delaying-adalimumab-biosimilars-in-the-US
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