Sandoz gains EU approval for Afqlir® (aflibercept), bolstering biosimilar lineup

On November 15, 2024, Sandoz, a prominent player in the field of generic and biosimilar medicines, announced that the European Commission (EC) has given the green light for the marketing of Afqlir® (aflibercept). Afqlir® will be available in 2 mg vial kits and pre-filled syringes for intravitreal injections, marketed as a biosimilar alternative to the reference medicine Eylea®. This approval signifies a significant advancement in the treatment of various retinal diseases, particularly neovascular age-related macular degeneration (nAMD), with the goal of preventing blindness associated with these conditions.

The approval of Afqlir® is a significant milestone for Sandoz, aligning with its strategy to drive growth through biosimilar products. The anticipated market launch is scheduled for the fourth quarter of 2025.

Claire D’Abreu-Hayling, Chief Scientific Officer at Sandoz, emphasized the importance of this approval, noting that vision loss greatly impacts daily activities and social interactions. She stated that providing early and expanded access to effective treatments is crucial for patients to maintain and improve their vision. This milestone reflects Sandoz’s commitment to enhancing patient outcomes through accessible and high-quality biosimilars.

Neovascular age-related macular degeneration (nAMD) is a subtype of age-related macular degeneration (AMD) and is characterized by central vision loss. It is a leading cause of vision impairment in individuals over the age of 65. Although nAMD accounts for only 10 to 20% of all AMD cases, it is responsible for 90% of severe vision loss due to AMD. Research indicates that approximately 3.6 million people in countries such as France, Germany, Italy, Spain, the UK, the US, and Japan suffer from nAMD. Out of these, 2.5 million are diagnosed, but only 1.7 million receive treatment.

Afqlir® contains the active ingredient aflibercept, a recombinant fusion protein that binds to vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF), inhibiting abnormal blood vessel growth. This mechanism helps improve visual acuity and prevent disease progression. The development program for Afqlir® included extensive analytical and preclinical in vitro studies, as well as clinical data from the Mylight study, confirming the biosimilar's efficacy and safety compared to its reference medicine.

Afqlir® is indicated for the treatment of various retinal conditions, including neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV). The approval of Afqlir® offers a more affordable and effective treatment option for patients in Europe suffering from these conditions, reinforcing Sandoz’s dedication to improving access to critical healthcare solutions.

Sandoz, headquartered in Basel, Switzerland, is a global leader in generic and biosimilar medicines. With a workforce of over 20,000 individuals from 100 nationalities, Sandoz provides treatments to approximately 800 million patients worldwide, generating significant healthcare savings and social impact. The company’s portfolio includes about 1,500 products, targeting a wide range of diseases from common ailments to serious conditions like cancer. Sandoz’s rich history of innovation dates back to its founding in 1886, with notable milestones including the introduction of Calcium Sandoz in 1929, the first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2023, Sandoz reported net sales of USD 9.6 billion, underscoring its significant role in the global healthcare landscape.