Comparable efficacy, safety found for wet AMD anti-VEGF biosimilars vs. reference drugs
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Key takeaways:
- A review of published data showed no difference in efficacy and safety between anti-VEGF biosimilars and reference products up to 1 year.
- More studies with longer follow-up are needed.
A review of currently available data suggests that there is little or no difference in efficacy and safety between anti-VEGF biosimilars approved for neovascular age-related macular degeneration and their reference products.
However, more long-term results are needed and could potentially modify these conclusions, the study authors noted.
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“The findings from our Cochrane review suggest that anti-VEGF biosimilars for neovascular AMD are comparable in safety and efficacy to their reference products. This is crucial as it supports the potential use of biosimilars as a viable, cost-effective alternative for managing this condition. Given the high costs associated with long-term treatment of neovascular AMD, biosimilars could significantly reduce financial barriers and improve access to the care for those who are affected worldwide,” co-author Sueko Matsumura Ng, MHS, a methodologist with the Cochrane Eyes and Vision US Project based at the University of Colorado Anschutz Medical Campus, told Healio.
Nine parallel-group multicenter randomized controlled trials that met high methodological standards were included, with sample sizes that ranged between 160 and 705 participants per study. Altogether, the studies enrolled 3,814 patients with neovascular AMD, one eye for each patient. The reference product was ranibizumab in seven studies and aflibercept in two studies. All studies were sponsored by industry. Five studies were conducted in Europe, North America and Asia, two in India, one in Japan and one in the Republic of Korea. The follow-up time ranged between 12 and 52 weeks, with a median of 48 weeks.
Meta-analyses of efficacy data showed no significant difference between biosimilars and reference products in terms of best corrected visual acuity change at 8 to 12 weeks and the proportion of patients losing fewer than 15 letters at 24 to 48 weeks. Vision-related quality of life was also similar. The safety profile was comparable, with a similar proportion of participants experiencing serious ocular adverse events in the biosimilar group (1.4%) and reference product group (1.2%), including retinal hemorrhage and endophthalmitis.
Biosimilars and reference products were also comparable in terms of production of anti-drug antibodies and mean maximum serum concentrations.
Ng said that continued research comparing biosimilars with branded drugs is important to better understand their equivalence in long-term safety and effectiveness, particularly to monitor for rare adverse events.
“Additionally, there is a need for more comprehensive data on certain biosimilars, especially those compared with aflibercept,” she said.
The authors noted that ongoing studies and studies of biosimilar agents that are in development may modify the review’s current conclusions.
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