On 9 October 2025, the US Food and Drug Administration (FDA) approved Celltrion’s Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron’s Eylea (aflibercept). On 17October 2025, the FDA approved expanded indications for Celltrion’s Yuflyma (adalimumab-aaty) and its unbranded version.
Eydenzelt (aflibercept-boav), Celltrion's first FDA-approved biological product in ophthalmology, is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD), macular oedema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR). The product has already been approved in the EU and Australia [1-3].
Eydenzelt is presented as a 2 mg (0.05 mL, 40 mg/mL) injection in a single-dose prefilled syringe (PFS) for intravitreal administration.
The FDA approval was based on a totality of evidence including analytical, nonclinical, and clinical evidence. A 52-week, phase III trial of 348 DME (diabetic macular oedema) patients compared Eydenzelt to Eylea. The primary endpoint of visual acuity change at week 8 met equivalence criteria. Secondary endpoints for efficacy, safety, and immunogenicity showed trends similar to Eylea.
Additionally, on 17 October 2025, the FDA approved expanded indications for Yuflyma (adalimumab-aaty) and its unbranded version, to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in paediatric patients aged 2 years and older.
Celltrion’s Yuflyma was approved in the US in May 2023 and launched in July 2023. It is currently available as a 20 mg, 40 mg, and 80 mg solution for injection in PFS, and as a 40 mg and 80 mg solution in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to improve patient affordability and meet differing needs.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EC approves eight biosimilars, six more await final authorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/news/ec-approves-eight-biosimilars-six-more-await-final-authorization
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of three aflibercept biosimilars: Ahzantive, Baiama, and Eydenzelt [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-three-aflibercept-biosimilars-ahzantive-baiama-and-eydenzelt
3. GaBI Online - Generics and Biosimilars Initiative. Australia biosimilar approvals in early 2025 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/news/australia-biosimilar-approvals-in-early-2025
4. GaBI Online - Generics and Biosimilars Initiative. Celltrion: advances for Yuflyma and Vegzelma biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Dec 5]. Available from: www.gabionline.net/biosimilars/news/celltrion-advances-for-yuflyma-and-vegzelma-biosimilars
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