EC approval for adalimumab biosimilar Idacio

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EC approval for adalimumab biosimilar Idacio

Biosimilares/Novedades | Posted 12/04/2019 0 Post your comment

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 3 April 2019 that it had received European Commission (EC) approval for its adalimumab biosimilar Idacio (MSB11455).

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].

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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

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Source: Fresenius Kabi