EMA recommends approval of first aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 11/08/2023 post-comment0 Post your comment

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Yesafili (aflibercept), an ophthalmology biosimilar, and Tyenne (tocilizumab), an immunosuppressant used largely for treatment of arthritis. 

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Yesafili is a biosimilar version of reference drug Eylea (aflibercept), which was authorised in the European Union (EU) on 22 November 2012 [1].

This originator is a blockbuster drug that had EU brand sales of approximately US$1.8 billion for the 12 months ending 31 December 2022, according to IQVIA. It is intended for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). 

Yesafili is the first biosimilar aflibercept to have received a positive opinion from the CHMP and will be available as a 40 mg/mL solution for injection. It is developed and marketed by Viatris and Biocon Biologics. The active substance of Yesafili, aflibercept, is an antineovascularisation agent. Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [2], a recombinant fusion protein consisting of human VEGF receptor 1 and VEGF receptor 2 extracellular domains fused to the Fc portion of human IgG1 [3], which acts as a soluble decoy for the natural VEGF receptors that inhibits their activation, thereby reducing pathological angiogenesis.

Tyenne is the first biosimilar of tocilizumab. This is a humanized monoclonal antibody against the interleukin-6 receptor (IL-6R). It is an immunosuppressive drug used mainly for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis, a severe form of arthritis in children. In Japan, tocilizumab is also approved for the treatment of Castleman’s disease, a rare benign tumour of B cells [3]. 

The Tyenne biosimilar medicine is intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne is the first biosimilar for this active substance.

The originator product, Roche’s Actemra/RoActemra (tocilizumab), was approved by the US Food and Drug Administration on 8 January 2010 and on 16 January 2009 by the European Medicines Agency [1]. The applicant for this medicinal product was Fresenius Kabi Deutschland GmbH. It is hoped that Tyenne will be available as a 20 mg/mL concentrate for solution for infusion and a 162 mg/mL solution for injection, when it goes to market.

Related articles
China approves tocilizumab copy biological BAT1806

Biocon to acquire biosimilars business from Viatris 

Clinical trials for aflibercept biosimilars 

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1. 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
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Aug 11]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab

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