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.

The approval by the EC follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive recommendation on 31 January 2019 for two adalimumab biosimilars from Fresenius Kabi – Idacio and Kromeya. The CHMP recommended that Idacio and Kromeya be approved for all the indications of the reference product (Humira) [1].

The EC approval of Idacio was based on a comprehensive data package submitted to EMA. Fresenius Kabi says that this data ‘demonstrated equivalent pharmacokinetics, efficacy, safety and immunogenicity to the reference product [Humira]’.

This marks Fresenius Kabi’s first biosimilar to be approved by the EC. The company acquired Merck KGaA’s biosimilars business in September 2017 after Merck KGaA decided to divest its biosimilars business [2]. Fresenius Kabi is also developing a pegfilgrastim biosimilar [3] and reported positive phase I results in October 2018 [4].

Related articles
Biosimilars of adalimumab

Biosimilars approved in Europe

References
1. 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 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-approval-for-adalimumab-biosimilars-Idacio-and-Kromeya 
2. GaBI Online - Generics and Biosimilars Initiative. Fresenius Kabi acquires Merck KGaA’s biosimilars business [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www.gabionline.net/Pharma-News/Fresenius-Kabi-acquires-Merck-KGaA-s-biosimilars-business 
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of pegfilgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-pegfilgrastim 
4. GaBI Online - Generics and Biosimilars Initiative. Positive phase I results for Fresenius Kabi’s pegfilgrastim biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Apr 12]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-results-for-Fresenius-Kabi-s-pegfilgrastim-biosimilar

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 © 2019 Pro Pharma Communications International. All Rights Reserved.