European Commission grants marketing authorization to aflibercept biosimilar from Sandoz Group

(Image Credit: AdobeStock/Andrey Kuzmin)

The European Commission (EC) granted marketing authorization for Afqlir (aflibercept), which is a 2 mg vial kit and pre-filled syringe for intravitreal injection. This is a biosimilar to reference aflibercept, known by the brand name, Eylea (Bayer AG). The biosimilar, Afqlir, is indicated to treat retinal diseases, including neovascular age-related macular degeneration (nAMD).¹

This approval is a notable milestone in the company’s growth.

Claire D’Abreu-Hayling, Chief Scientific Officer for Sandoz, is quoted in the press release1 discussing the news as saying, "Vision loss significantly affects daily activities, from work to social interactions. Early and expanded access to effective treatments is essential for patients to maintain and improve their visual acuity. The approval of Afqlir is a pivotal moment in delivering an affordable and effective treatment option to patients in Europe who are affected by conditions such as nAMD. This milestone underscores our commitment to improving patient outcomes through accessible, high-quality biosimilars."

A launch of this biosimilar is expected as of Q4 2025.¹

Reference:

1. Sandoz receives European Commission approval for Afqlir® (aflibercept), further strengthening leading biosimilar portfolio. Sandoz Group. November 15, 2024. Accessed November 15, 2024. https://www.globenewswire.com/news-release/2024/11/15/2981760/0/en/Sandoz-receives-European-Commission-approval-for-Afqlir-aflibercept-further-strengthening-leading-biosimilar-portfolio.html