The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy. | Image Credit: Witoon - stock.adobe.com
Ranibizumab biosimilar (Ongavia) offers a lower cost alternative for neovascular age-related macular degeneration (nAMD) treatment, resulting in significantly less visual improvement and reduced retinal thickness reduction compared with aflibercept (Eylea), especially when strict monthly injection schedules were not maintained, according to a study published in Cureus.1
Individuals aged 50 years and older have an increased risk of developing age-related macular degeneration (AMD) since it is the leading cause of severe visual impairment and blindness, accounting for over 8.7% of global blindness. In nAMD, the abnormal blood vessels grow under the retinal pigment epithelium and into the macula, causing fluid leakage, hemorrhage, and fibrosis, which leads to central vision impairment.
Vascular endothelial growth factor (VEGF) plays a vital role in the pathogenesis of nAMD, and anti-VEGF therapies are a common treatment for nAMD to prevent angiogenesis and fluid leakage to preserve macular function and vision. The FDA approved the anti-VEGF agents ranibizumab (Lucentis) and aflibercept in 2006 and 2011, respectively.
The patent for ranibizumab, a humanized monoclonal antibody fragment targeting VEGF growth factor A, expired in June 2020, allowing the development of biosimilars. Ongavia is a ranibizumab biosimilar that was developed by Teva Pharmaceuticals for the treatment of several ophthalmic conditions by the UK Medicines & Healthcare Regulatory Agency in May 2022.2 Ongavia costs a lot less than the originator, offering an economically attractive option for health care systems under financial strain.1
“We aim to provide insights into the comparative performance of these anti-VEGF agents under real-world conditions, addressing both clinical efficacy and resource implications,” study authors stated.
Researchers conducted a single-center retrospective audit at a tertiary hospital ophthalmology medical retina unit and evaluated 2 types of intravitreal anti-VEGF injections initiated for new presentations of nAMD to the medical retina department. The study included 12 months of post-initial intravitreal injection outcome data from August 2022 to August 2024.
There was a total of 62 eyes that met the inclusion criteria, with 34 women and 28 men. Patients receiving Eylea (n = 36) had a significantly greater improvement in best-corrected visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letters of 7.08 (4.12) compared with Ongavia (n = 26) with –1.9 (3.31; P = .018). The mean initial and end point BCVA for Eylea was 50.7 and 57.8 ETDRS letters, respectively. The mean initial and end point BCVA for Ongavia was 53.7 and 51.8 ETDRS letters, respectively.
Eylea demonstrated a greater reduction in central retinal thickness (CRT), decreasing it by 116.21 μm (35.61 μm), compared with Ongavia, which reduced CRT by 51.41 μm (22.21 μm; P = .002). The mean initial and end point CRT for Eylea was 330.8 μm and 214.6 μm, respectively. The mean initial and end point CRT for Ongavia was 318.8 μm and 267.7 μm, respectively.
On average, patients received injection intervals of 9.49 weeks for Eylea compared with 8.17 weeks for Ongavia. Researchers prescribed 164 out of 171 (96%) Ongavia injections at 4-week intervals, compared with 110 out of 207 (53%) Eylea injections. They prebooked the first 3 intravitreal injections for 4-week intervals but administered the second injection at an average of 5.3 weeks for Ongavia and 5 weeks for Eylea. They administered the third injection at an average of 6.4 weeks for Ongavia and 6.6 weeks for Eylea.
Regarding costs, biosimilar launches have resulted in both a 53% market share in biosimilar markets and a 53% reduction in average drug costs after 5 years of biosimilar competition, based on Samsung Bioepis’ First Quarter 2025 Biosimilar Market Report.3 However, data indicate that immunology and ophthalmology biosimilars yielded smaller discounts than oncology biosimilars.
The study may be limited by potential selection bias that could affect the visual gains data along with logistical challenges.
“Future studies should perform a thorough cost analysis to investigate the long-term cost implications and clinical efficacy of biosimilars under various administrative constraints to help guide their implementation,” study authors concluded.
References
1. Bilal A, Bilal M, Usman D, Elahi A, Al-Bermani A. A tertiary centre's experience with using ranibizumab biosimilar compared to aflibercept for neovascular age-related macular degeneration: a retrospective study. Cureus. 2024;16(12):e75586. Published 2024 Dec 12. doi:10.7759/cureus.75586
2. Jeremias S. Teva’s Lucentis biosimilar gains UK approval. The Center for Biosimilars®. May 17, 2022. Accessed March 31, 2025. https://www.centerforbiosimilars.com/view/teva-s-lucentis-biosimilar-gains-uk-approval
3. Jeremias S. Biosimilars drive cost savings and achieve 53% market share across treatment areas. The Center for Biosimilars. January 16, 2025. Accessed March 31, 2025. https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas