Sandoz Launches Afqlir in Europe: A New Biosimilar Option for Retinal Disease Treatment

Sandoz has officially launched Afqlir, its biosimilar referencing aflibercept, across European markets. Approved by the European Commission in November 2024, Afqlir is available in a 2 mg vial kit and pre-filled syringe for intravitreal injection. It is authorized for the same indications as Eylea, including the treatment of neovascular age-related macular degeneration (nAMD), retinal vein occlusion (RVO), and diabetic macular edema (DME) in adult patients. Clinical data confirm that Afqlir is equivalent to the reference product in efficacy, safety, and pharmacokinetics.

Addressing the Rising Burden of Retinal Diseases

Retinal diseases such as nAMD, RVO, and DME are among the leading causes of vision loss globally, with increasing prevalence. Aflibercept is widely regarded as a gold-standard therapy for managing these conditions. nAMD, a subtype of AMD, is particularly severe, accounting for only 10–20% of AMD cases but 90% of related vision loss. An estimated 4 million people across major markets including France, Germany, Italy, Spain, the UK, the US, and Japan live with nAMD, yet only 2 million currently receive treatment.

Launch Strategy and Market Impact

Afqlir is launching across Europe, beginning in the UK, with subsequent rollouts planned in key markets like Germany and France, and further expansion expected in 2026. Afqlir strengthens Sandoz’s position in the ~$15 billion anti-VEGF ophthalmology market and aligns with the company’s goal of improving access to high-quality, affordable biologics.

“Vision loss can devastate lives, affecting not only those living with conditions like nAMD but also the families and caregivers who support them,” said Christophe Delenta, President Europe, Sandoz. “At the same time, the high cost of current treatments for neovascular retinal diseases places further strain on healthcare systems. That’s why the launch of Afqlir is such an important milestone: It brings a high-quality, affordable aflibercept option for European patients that maintains and improves vision, while also supporting more sustainable care across the region.”