A phase I clinical trial of Minapharm Pharmaceuticals’ first African developed adalimumab biosimilar, Adessia, was initiated on 24 February 2023 in Germany with results to be expected at the end of 2023.
This follows a prior announcement made by Minapharm Pharmaceuticals on 13 February 2023 reporting that said Phase I trial received unconditional approval from the Paul-Ehrlich Institut.
The approved trial is a multi-centre, randomized, double-blind, 2-arm, parallel group trial in 154 healthy male and female participants, comparing the pharmacokinetics, safety, immunogenicity and tolerability of the adalimumab biosimilar, Adessia, and its reference product AbbVie’s Humira. Adessia was developed by Minapharm and has been submitted for approval by the Egyptian health authorities.
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 [1].
The originator product, AbbVie’s Humira (adalimumab), was approved by the US Food and Drug Administration (FDA) in December 2002 and by the European Medicines Agency (EMA) in September 2003 [2].
There have been several patent disputes that have meant that in some regions the launch of biosimilar versions of adalimumab have been delayed [3-5]. However, several biosimilars of the product have been approved and are available for patients [1]. Adessia hopes to join these biosimilar versions of adalimumab following the successful completion of clinical trials.
‘Our ambition for Africa and the transformation of health care is clear: health care is a human right and testing the first ever in Africa (Egypt) developed monoclonal antibody biosimilar candidate in healthy volunteers in an EMA-regulated country speaks to the quality of analytical data obtained so far and accepted by Paul-Ehrlich Institut. Our approach remains holistic and patient centric and directed towards addressing unmet medical needs in Egypt, the Middle East and all of Africa’, said Dr Lutz Hilbrich, Chief Executive Officer at ProBioGen and MiGenTra and Chief Medical Officer at MiGenTra.
MiGenTra, Berlin-based healthcare transforming company, and Minapharm Pharmaceuticals are jointly responsible for filing and commercialising Adessia in Africa and the Middle East.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 5] Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Amgen’s adalimumab biosimilar will only be launched in US in 2023 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 5] Available from:
www.gabionline.net/Biosimilars/News/Amgen-s-adalimumab-biosimilar-will-only-be-launched-in-US-in-2023
4. GaBI Online - Generics and Biosimilars Initiative. AbbVie and Samsung Bioepis reach patent deal over Humira biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 5] Available from:
www.gabionline.net/Biosimilars/General/AbbVie-and-Samsung-Bioepis-reach-patent-deal-over-Humira-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. The latest biosimilars agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Apr 5]. Available from:
www.gabionline.net/Biosimilars/News/The-latest-biosimilars-agreements
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