On October 9, Celltrion, Inc. announced it had received the nod from the FDA on the latest aflibercept biosimilar, Eydenzelt (aflibercept-boav). This Eylea biosimilar is indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Celltrion will join a heavily competitive field when it does launch, as it is the sixth aflibercept biosimilar to receive approval in the US. “Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have Eydenzelt approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the US,” said Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA.
Outside of Amgen’s at-risk marketing of Pavblu, which launched a year ago, it is likely that other aflibercept biosimilars won’t launch until at least mid-2026. In an Email to BR&R, a Celltrion spokesperson stated, “At this time, we are engaged in ongoing litigation concerning the US launch of Eydenzelt. As the legal proceedings progress, the final decision regarding the product’s availability will be determined. We are committed to ensuring that all regulatory and legal considerations are thoroughly addressed to facilitate timely access to Eydenzelt for patients in need.” Interestingly, Celltrion also has a bevacizumab biosimilar (Vegzelma). Though not approved by the FDA for ophthalmologic indications, bevacizumab is often used in compounded formulations to provide a very low-cost alternative to ranibizumab and aflibercept and is typically covered by payers. The extent to which one of the several bevacizumab biosimilars versus the reference product Avastin is used to treat retinal disease is unknown.
