EMA accepts application for high concentration adalimumab biosimilar

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EMA accepts application for high concentration adalimumab biosimilar

Biosimilares/Novedades | Posted 08/07/2022 0 Post your comment

Sandoz, the generics division of Novartis, announced on 17 June 2022 that the European Medicines Agency (EMA) has accepted the application for its high concentration formulation (HCF) of its adalimumab biosimilar Hyrimoz (GP2017).

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.

Sandoz is seeking approval for Hyrimoz HCF in the same indications as the reference biological, AbbVie’s Humira (adalimumab).

The application is supported by a comprehensive submission package, which includes a phase I pharmacokinetics bridging study comparing Hyrimoz 50 mg/mL and Hyrimoz HCF (100 mg/mL). According to Sandoz, this study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the 50 mg/mL Hyrimoz formulation and Hyrimoz HCF (100 mg/mL).

Sandoz says that, upon approval, Hyrimoz HCF citrate-free would offer reduced injection volume and potentially decrease the number of injections required for patients who need 80 mg dosing. Hyrimoz HCF will have the same auto injector as the 50 mg/mL Hyrimoz formulation, a fact that Sandoz claims will give ‘an enhanced yet familiar patient experience’.

Sandoz already has 10 biosimilars approved in the European Union [1] and four in the US [2]. EMA has already approved two other high-concentration adalimumab biosimilars. Hukyndra and Libmyris are both high-concentration (100 mg/mL) biosimilars of Alvotech’s proposed biosimilar AVT02 [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-approved-in-the-US
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of two adalimumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Jul 8]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-two-adalimumab-biosimilars

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Source: Sandoz