European Commission grants marketing authorisation for aflibercept biosimilar Afqlir (Sandoz Group)

The biosimilar is expected to launch as of Q4 2025. Image credit: ©olrat – stock.adobe.com

The European Commission (EC) granted marketing authorisation for Afqlir (aflibercept), which is a 2 mg vial kit and pre-filled syringe for intravitreal injection. Afqlir, produced by Sandoz Group, is a biosimilar to reference aflibercept, known by the brand name Eylea (Bayer AG). The biosimilar is indicated to treat retinal diseases, including neovascular age-related macular degeneration (nAMD), macular oedema following retinal vein occlusion, diabetic macular oedema and myopic choroidal neovascularisation, according to a press release about Afqlir from Sandoz Group.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 release discussing the news. She stated, "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."

The biosimilar is expected to launch by Q4 2025.¹

According to the company, the active ingredient in Afqlir is aflibercept, a recombinant fusion protein and anti-vascular endothelial growth factor A (VEGF-A) agent. "The robust biosimilar development program of Afqlir consisted of a comprehensive package including analytical and preclinical in vitro study data, as well as clinical data from the Mylight study," the press release detailed. These study findings confirmed that the biosimilar displays equivalent efficacy and comparable safety to its reference medicine.

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