Biosimilar Mvasi Demonstrates Similar Ophthalmic Safety Profile to Reference Product Avastin

Bevacizumab-awwb (Mvasi; Amgen), a biosimilar of reference bevacizumab (Avastin; Genentech), demonstrated a similar ophthalmic safety profile in patients with retinal disease when administered intravitreally. These findings were published in Clinical & Experimental Ophthalmology, and the authors wrote that the development of an on-label bevacizumab specifically approved for ophthalmic use could provide enhanced quality, safety, and sterility for patients.¹

Image credit: TatjanaMeininger | stock.adobe.com

Mvasi is a vascular endothelial growth factor (VEGF) inhibitor that is indicated on its own and as a combination therapy in various disease states, including metastatic colorectal cancer, non–small cell lung cancer, glioblastoma, metastatic cervical cancers, renal cell carcinoma, and others. It was FDA-approved as a biosimilar to Avastin in September 2017, and according to the FDA, it was the first biosimilar approved in the US as a treatment for cancer. Its initial approval was based on comparisons of extensive structural and functional product characterization, animal data, human pharmacokinetic and pharmacodynamic data, as well as clinical immunogenicity data demonstrating Mvasi’s high similarity to Avastin without clinically meaningful differences.^2,3

The investigators wrote that the off-label use of bevacizumab in ophthalmology began in 2005 when it was found to be effective in the treatment of neovascular age-related macular degeneration. Because there is limited safety data for this off-label use, the investigators conducted a retrospective study to evaluate its safety within this space.¹

For this study, the investigators gathered data from patients who were given intravitreal Mvasi at all metropolitan public hospitals in South Australia between May 1, 2022, and May 30, 2024. Data including demographic information, injection indications, the number of injections per eye, whether patients switched to another treatment, as well as any associated complications were collected from both electronic and paper medical records and evaluated.

A total of 6230 injections were administered in 1682 eyes over the course of this study. The mean age of the population was about 69.8 ± 15.6 years, and the overall mean number of Mvasi injections given per eye was 3.7 ± 2.9 (range: 1–21). Mvasi was most commonly used to treat neovascular age-related macular degeneration (n = 2106 injections; 33.8%), followed by diabetic macular oedema (n = 1634; 26.2%), branch retinal vein occlusion (n = 695; 11.2%), proliferative diabetic retinopathy (n = 596; 9.6%), central retinal vein occlusion (n = 558; 9.0%) and other (n = 641; 10.3%). There were 6 sight-threatening complications included in the study, of which 3 were cases of bacterial endophthalmitis (0.05%) and the other 3 were uveitis (0.05%). No cases of retinal vasculitis were observed.¹

Systemic adverse events (AEs) were not a focus of this study, the authors wrote. Although prior data have reported Avastin may be associated with some systemic AEs, it is unclear whether Mvasi would also be associated with some of these AEs. In this large retrospective study, off-label intravitreal use of Mvasi was shown to have a similar ocular safety profile to that reported for other intravitreal anti-VEGF agents, providing a reasonable alternative to Avastin where this drug may be unavailable or inaccessible. The authors urged for real-world clinical experience regarding biosimilars for ophthalmic use.¹

“Health care providers must prioritize evidence-based practice over cost incentives, advocating for research that confirms the suitability of these biosimilars for ophthalmic use, with patient safety as the primary consideration,” concluded the authors. “Given that both Avastin and Mvasi require compounding into smaller doses for intraocular use, this process introduces sterility risks and variability. Development of an on-label bevacizumab (specifically approved for ophthalmic use) could provide enhanced quality, safety, and sterility; however, it may also increase the cost significantly.”¹

REFERENCES

1. Wang H, Bahrami B, Huang S, et al. Safety of an Intravitreal Bevacizumab Biosimilar (MVASI). Clin Exp Ophthalmol. 2025;53(5):523-528. doi:10.1111/ceo.14515

2. Amgen. MVASI (bevacizumab-awwb). Accessed July 29, 2025. https://www.mvasi.com/hcp

3. US Food & Drug Administration. FDA approves first biosimilar for cancer treatment. News release. Updated December 21, 2017. Accessed July 29, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-first-biosimilar-cancer-treatment