Sandoz to file for approval of aflibercept biosimilar

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

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

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.