Swiss pharmaceutical firm Sandoz announced that the European Commission (EC) has approved Afqlir (aflibercept) 2 mg vial kit and pre-filled syringe for intravitreal injection.
Afqlir is a biosimilar to reference medicine Eylea and is indicated to treat retinal diseases, including neovascular age-related macular degeneration (nAMD) to help prevent blindness.
Sandoz said Afqlir is a key biosimilar for the company, driving significant value. This approval marks a major milestone in Sandoz’s growth strategy.
The biosimilar is expected to launch in Q4 2025.
Sandoz chief scientific officer Claire D’Abreu-Hayling said: “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.”
Afqlir contains aflibercept, a recombinant fusion protein that targets vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF).
This action helps inhibit abnormal blood vessel growth in the eye. Aflibercept is injected into the eye to improve vision and slow disease progression.
The development of the biosimilar was backed by a comprehensive biosimilar programme, including analytical, preclinical, and clinical data from the Mylight study.
This evidence confirmed that Afqlir offers equivalent efficacy and comparable safety to its reference medicine.
The product is approved to improve and maintain visual acuity in patients with nAMD, macular oedema from retinal vein occlusion (RVO), diabetic macular oedema (DME), and myopic choroidal neovascularisation (mCNV).
Eylea was jointly developed by Regeneron and Bayer. In August 2023, the US Food and Drug Administration (FDA) approved Eylea HD Injection 8 mg to treat certain ophthalmic disorders.
In September 2023, Biocon Biologics, a subsidiary of Biocon received EC marketing authorisation for Yesafili, a biosimilar of aflibercept, in the European Union (EU).
Afqlir was approved in the US as Enzeevu in August this year to treat nAMD.
In July 2024, South Korea-based Altos Biologics submitted an EMA Marketing Authorization Application (MAA) for an aflibercept biosimilar ALT-L9.
