First African developed biosimilar adalimumab starts phase I trial in Germany

Biosimilares/Novedades | Posted 06/04/2023 post-comment0 Post your comment

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.

Clinical trial PainSA V21F04

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. 

Related articles
China approves adalimumab copy biological Sulinno

Cadila Pharmaceuticals launches two similar biologics in India

Amgevita approved in Colombia

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: La UE y América Latina/Caribe lanzan un mercado virtual de productos farmacéuticos

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: La UE y América Latina/Caribe lanzan un mercado virtual de productos farmacéuticos

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2023 Pro Pharma Communications International. All Rights Reserved.

 

comment icon Comments (0)
Post your comment
Related content
Canadá aprueba tres biosimilares más en 2022
Health Canada V13I20
Biosimilares/Novedades Posted 28/05/2024
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010