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Sandoz to file for approval of aflibercept biosimilar

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Sandoz intends to seek regulatory approval for its aflibercept biosimilar in the US and EU in the coming months.

https://www.europeanpharmaceuticalreview.com/news/181820/injectable-small-molecule-inhibitor-could-improve-vision/

Sandoz has announced positive results from the MYLIGHT Phase III study for its biosimilar aflibercept, for patients living with wet macular degeneration.

 

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The confirmatory efficacy and safety study (NCT04864834) demonstrated therapeutic equivalence between the biosimilar aflibercept and the reference biologic, Eylea®.

The study met its primary efficacy endpoint, showing therapeutic equivalence in mean change of best corrected visual acuity (BCVA) from baseline to week 8 between the biosimilar aflibercept and Bayer AG’s/Regeneron Pharmaceutical’s Eylea®. 

Safety, immunogenicity, and pharmacokinetics results also confirmed no clinically meaningful difference between the products.

Aflibercept is a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal vessel growth. Aflibercept is injected into the eye of patients with neovascular retinal diseases, like neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or retinal vein occlusion (RVO), to improve visual acuity and inhibit disease progression.

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“This important milestone, confirming therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology,” commented Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz.

Aflibercept is one of four high-value biosimilars that Sandoz plans to launch over next few years. The company, a division of Novartis, currently has a portfolio of eight marketed biosimilars, with a further 24 in various development stages. Sandoz launched its first biosimilar – somatropin (Omnitrope) – in Europe in 2006.

Sandoz said it expects to file for regulatory approval for biosimilar aflibercept in the US and European Union in the coming months.

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