There is little to no difference in terms of effectiveness and safety between anti-vascular endothelial growth factor (anti-VEGF) medications and biosimilars used to treat neovascular age-related macular degeneration (nAMD), researchers from the Department of Ophthalmology at the University of Colorado School of Medicine say in a new Cochrane Eyes and Vision systematic review.
Biosimilars, nearly identical versions of complex biologic drugs made from living cells, often come at a fraction of the price as original medications, making them a cost-effective option for patients who rely on the intravitreal injections to improve visual acuity and prevent vision loss caused by nAMD, which affects an estimated 196 million people worldwide.
“There is a huge market for biosimilars because there is a growing population of people who are affected by AMD,” says Tianjing Li, MD, PhD, associate professor of ophthalmology and director for the Cochrane Eyes and Vision U.S. Project hosted at the Sue Anschutz-Rodgers Eye Center. “Knowing that biosimilars are just as safe and effective can help clinicians around the world make informed decisions and feel comfortable with using a more cost-effective treatment for patients who might not be able to afford the original anti-VEGF medicines.”
“This review showcases international collaboration on a highly relevant and impactful research question and was made possible through the generous funding from the National Eye Institute,” she continues.
Improving global access to treatment
European countries where treatment decisions are influenced by cost considerations are expected to use the findings from the review to inform practice guidelines.
The systematic review, completed together with researchers at Japan’s Showa University, highlights results from nine high-quality randomized control trials that compared approved anti-VEGF treatments with biosimilars. In total, studies included nearly 4,000 participants.
Anti-VEGF medications work to inhibit the growth of abnormal blood vessels under the retina and limit damage that causes vision loss. Most nAMD patients require regular injections of anti-VEGF medications into their eyes.
From the included studies, Cochrane researchers conclude that there is little to no difference between the original medicines and the biosimilars for vision-related wellbeing and serious eye-related unwanted events following the injections.
Naresh Mandava, MD, professor and chair of the Department of Ophthalmology, says these findings "are a result of a rigorous analysis of the available literature, and I do believe biosimilars have an important role in treating patients with AMD and other retinopathies. It is important to note that immunogenicity can be an issue with intravitreal injections and sometimes inflammation is not seen except when many thousands of patients are treated."
“It will be important to follow these drugs in the real world to look for signals of these adverse events and to follow up on this seminal work with more systematic reviews as more on going studies are published,” continues Mandava, who is the Sue Anschutz-Rodgers Chair in Retinal Diseases and executive director of the Sue Anschutz Rodgers Eye Center.
Following future research outcomes
The first anti-VEGF medication available to AMD patients was approved by the U.S. Food and Drug Administration (FDA) in 2006. Biosimilars are much newer to the market, the latest being approved just this month, and less expensive because a different approval pathway for biosimilars.
“There’s an abbreviated pathway to approval from the FDA which contributes to the lower cost,” explains Sueko Ng, MHS, a CU ophthalmology researcher, methodologist with Cochrane Eye and Vision U.S., and co-author of the review. “Pharmaceutical companies that produce the biosimilars save a lot of money through this process and that ends up benefiting the patient down the road.”
With the expected rise in popularity of biosimilars, researchers say they’re likely to have more data in the future and are looking forward to following the research as it becomes available.
“The review identified 19 ongoing studies,” says Alison Su-Hsun Liu, MD, PhD, assistant research professor of ophthalmology and project director for Cochrane Eyes and Vision U.S. “Our researchers anticipate many of these studies to publish within the next two years, which will allow us to update this review.”
Those studies will offer more insight to the benefits of biosimilars, especially longer term safety data and quality of life and economic impacts.
