EC approval of natalizumab, aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 28/11/2023 post-comment0 Post your comment

In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).

Approved-V13G05

Tyruko (natalizumab)
On 26 September 2023, Sandoz announced that its natalizumab biosimilar, Tyruko, had received EC approval. This is now the first and only biosimilar for multiple sclerosis in Europe.  This product has also been approved in the US on 24 August 2023 [1]. It is a biosimilar of Biogen and Elan’s Tysabri (natalizumab).

Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin. Natalizumab is believed to work by reducing the ability of inflammatory immune cells to attach to and pass through the cell layers lining the intestines and blood–brain barrier. Natalizumab is indicated for the treatment of MS (US and Europe) and Crohn’s disease (US) [2].

The EC has approved Tyruko for all indications of the reference medicine.

The EC approval follows a positive opinion issued on 20 July 2023 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union Member States plus Iceland, Norway and Liechtenstein [3].

The positive CHMP opinion was supported by evidence from extensive analytical characterization confirming similarity of biosimilar with reference biological, in addition to phase I and confirmatory phase III studies in relapsing-remitting multiple sclerosis (RRMS) patients.

Yesafili (aflibercept)
On 20 September 2023, Biocon announced that its aflibercept biosimilar, Yesafili, had received EC approval on 15 September 2023. It is a biosimilar of the reference product Regeneron’s Eylea (aflibercept).

Biocon Biologics and Viatris’ Yesafili (aflibercept) is an ophthalmology product, 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) [4].

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor [5], a recombinant fusion protein consisting of human VEGF receptor 1 and VEGF receptor 2 extracellular domains fused to the Fc portion of human IgG1 which acts as a soluble decoy for the natural VEGF receptors that inhibits their activation, thereby reducing pathological angiogenesis.

In addition to Yesafili, Biocon has three other biosimilars approved by the EC, they are: Kirsty (previously Kixelle, insulin aspart, 2021), Ogivri (trastuzumab, 2018), and Semglee (insulin glargine, 2018) [6].

Tyenne (tocilizumab)
On 19 September 2023, Fresenius Kabi announced that its tocilizumab biosimilar, Tyenne had received EC approval on 15 September 2023.

Tyenne, Fresenius Kabi’s tocilizumab biosimilar, is the first biosimilar of its kind to be approved in Europe, referencing Roche’s Actemra/RoActemra (tocilizumab).

Fresenius Kabi has submitted an application to the US Food and Drug Administration (FDA) on 1 August 2022 [7].

Tocilizumab is a humanized monoclonal antibody which acts 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 [8].

The EC has approved Tyenne for the treatment of various inflammatory and immune mediated conditions, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome (CRS) as well as for the treatment of COVID-19. Tyenne is available in both subcutaneous and intravenous formulations.

Tyenne is the Fresenius Kabi’s third biosimilar granted marketing authorization by the EC, following previous approvals of its commercially available biosimilars Stimufend (pegfilgrastim) and Idacio (adalimumab) in 2022 and 2019, respectively [6].

Both the biosimilar aflibercept Yesafili and tocilizumab Tyenne received a positive opinion from EMA’s CHMP on 20 July 2023 [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first natalizumab biosimilar Tyruko for MS [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-natalizumab-biosimilar-tyruko-for-ms
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of natalizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-natalizumab
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first natalizumab biosimilar Tyruko for MS [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-natalizumab-biosimilar-tyruko-for-ms
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of first aflibercept and tocilizumab biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-first-aflibercept-and-tocilizumab-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe
7. GaBI Online - Generics and Biosimilars Initiative. FDA accepts application for tocilizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/news/fda-accepts-application-for-tocilizumab-biosimilar
8. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of tocilizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Nov 28]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-tocilizumab

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