• Bone Health
  • Immunology
  • Hematology
  • Respiratory
  • Dermatology
  • Diabetes
  • Gastroenterology
  • Neurology
  • Oncology
  • Ophthalmology
  • Rare Disease
  • Rheumatology

Bevacizumab Biosimilar Fills Gap for Retinal Disease With Encouraging Safety Data

News
Article

Real-world data confirm Mvasi's safety as a cost-effective alternative to reference bevacizumab (Avastin) for treating retinal conditions.

bevacizumab for amd | Image Credit: Orawan - stock.adobe.com

As clinicians in Australia search for alternatives following the loss of subsidized Avastin (reference bevacizumab), many have turned to Mvasi—an oncology-approved biosimilar—using it off-label to manage a wide range of sight-threatening retinal conditions. | Image Credit: Orawan - stock.adobe.com

As clinicians in Australia search for alternatives following the loss of subsidized Avastin (reference bevacizumab), many have turned to Mvasi—an oncology-approved biosimilar—using it off-label to manage a wide range of sight-threatening retinal conditions. Now, real-world data from South Australia’s public hospitals suggest that this practice is not only widespread but also safe.

“While anti-VEGF [vascular endothelial growth factor] biosimilars approved for oncology may offer cost savings, their use in ophthalmology without dedicated trials raises ethical and safety concerns. Off‐label adoption without ophthalmic‐specific studies risks exposing patients to harm.… Healthcare providers must prioritise 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,” wrote the authors.

In a large retrospective review, researchers evaluated 6,230 intravitreal Mvasi (bevacizumab-awwb) injections administered to 1682 eyes between May 2022 and May 2024. The study found low rates of adverse events, with only 3 cases each of bacterial endophthalmitis and uveitis (0.05%), and no cases of retinal vasculitis—results comparable to those seen with reference bevacizumab.

The findings offer critical reassurance for ophthalmologists and health systems relying on biosimilars to fill the gap left by Avastin, which was discontinued from Australia’s Pharmaceutical Benefits Scheme (PBS) in 2021 due to commercial reasons. Mvasi, though not specifically approved for ocular use, has since become a go-to anti-VEGF therapy in public hospitals for conditions such as neovascular age-related macular degeneration and diabetic macular edema.2

In response, researchers reviewed more than 6000 injections of Mvasi—a biosimilar to Avastin—administered across South Australia’s public hospital system between May 2022 and May 2024.1

The retrospective review, published in a recent abstract, analyzed 6230 intravitreal MVASI injections administered in 1682 eyes. The study found that Mvasi had a strong safety profile, with sight-threatening complications occurring in less than 0.1% of cases. There were 3 reported cases of bacterial endophthalmitis (0.05%) and 3 of uveitis (0.05%), and no cases of retinal vasculitis.

“These complication rates are consistent with what we see with reference bevacizumab and other anti-VEGF agents,” the authors noted. “This supports Mvasi as a practical alternative for continued high-quality retinal care in Australia.”

The study population had a mean age of 69.8 years. The most frequent treatment indications were neovascular age-related macular degeneration (33.8% of injections), diabetic macular edema (26.2%), and retinal vein occlusions. On average, patients received 3.7 injections per eye.

Prior to this study, safety data for intravitreal Mvasi had been limited, as most research centered on its systemic use in oncology. The findings are especially timely given the global interest in expanding biosimilar use to curb drug costs while maintaining patient safety.

“Real-world data like this is critical, especially for off-label biosimilar use,” said one biosimilar market analyst. “It helps build clinician and regulatory confidence, particularly in therapeutic areas like ophthalmology where the margin for error is very small.”

The implications extend beyond Australia. In the US, while biosimilars for ranibizumab and aflibercept have entered the ophthalmology market, bevacizumab biosimilars such as Mvasi are not yet FDA approved for intravitreal use. Nevertheless, some physicians prescribe them off label due to affordability and access considerations.

The study highlights the importance of continued postmarket surveillance to detect rare complications and evaluate biosimilars in real-world clinical settings. As biosimilar adoption grows globally, especially in cost-sensitive markets, robust safety data will be crucial for integrating these products into routine care.

With mounting evidence, Mvasi could help fill the gap left by Avastin and ensure continued access to sight-saving treatments—particularly in public health systems where affordability and availability are paramount.

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. Ateeq A, Tahir MA, Cheema A, Darhi A, Tareen S. Intravitreal injection of bevacizumab in diabetic macular edema. Pak J Med Sci. 2014;30(6):1383-1387. doi:10.12669/pjms.306.5738

Newsletter

Where clinical, regulatory, and economic perspectives converge—sign up for Center for Biosimilars® emails to get expert insights on emerging treatment paradigms, biosimilar policy, and real-world outcomes that shape patient care.

Recent Videos
Travis Brewer, Texas Oncology
Tiago Biachi, MD, PhD
Brian Biehn
GBW 2023 webinar
Ryan Haumschild, PharmD, MS, MBA
"SEEING EYE TO EYE:  Exploring Different Perspectives on Ophthalmology Biosimilars SEEING EYE TO EYE:  Exploring Different Perspectives on Ophthalmology Biosimilars" with the CfB logo and an image of an eye
Julie Reed, executive director of the Biosimilars Forum
Ryan Haumschild, PharmD, MS, MBA
andre harvin
Here are the top 5 biosimilar articles for the week of May 1, 2023.
Related Content
© 2025 MJH Life Sciences

All rights reserved.