Sandoz Launches Afqlir® (aflibercept) in Europe, Offering a More Affordable Option for Patients with Retinal Diseases
Wednesday, November 26, 2025
Sandoz has introduced Afqlir® (aflibercept) in Europe, expanding access to treatment for adults with various retinal diseases. The product, supplied as a 2 mg vial kit and a pre-filled syringe for intravitreal injection, received European Commission approval in November 2024. Afqlir® is authorised for the same uses as the reference medicine Eylea®, including the treatment of several retinal conditions that can lead to vision loss. Clinical studies have shown that Afqlir® matches the reference product in terms of efficacy, safety and pharmacokinetics.
Aflibercept is widely regarded as a key treatment for neovascular retinal diseases. Conditions such as age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular oedema are among the main causes of vision impairment worldwide, with the number of affected patients continuing to grow.
Neovascular age-related macular degeneration (nAMD), a form of AMD, leads to vision loss in the central field of vision and is a major cause of severe visual impairment in people over 65. Although nAMD accounts for a smaller proportion of total AMD cases, it is responsible for the vast majority of serious vision loss linked to the disease. Across major markets including France, Germany, Italy, Spain, the UK, the US and Japan, an estimated four million people are affected by nAMD. Of these, 2.8 million have been diagnosed, but only about two million receive treatment.
Afqlir® will be introduced gradually across Europe, starting with the UK, followed by Germany and France, with wider availability expected in 2026.
The launch strengthens the Sandoz biosimilar portfolio and forms part of the company’s broader growth strategy. It follows recent introductions of biosimilars such as Tyruko® (natalizumab), Wyost® (denosumab) and Jubbonti® (denosumab) in the United States.
Sandoz aims to support access to essential biologic treatments through a broad and expanding biosimilar portfolio. The company currently offers 13 biosimilars worldwide, with an additional 27 in development. Afqlir® also reinforces the company’s long-standing leadership in biosimilars and enhances its position in the global anti-VEGF ophthalmology market, valued at around USD 15 billion.
In September 2025, Sandoz reached an agreement with Regeneron Pharmaceuticals, Inc. to resolve all patent-related disputes concerning its FDA-approved aflibercept biosimilar. This agreement clears the way for the planned US launch of Enzeevu™ (aflibercept-abzv) by the end of 2026.
Source: sandoz.com
