The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.
Bayer has announced that the European Commission has approved a new treatment regimen for aflibercept (Eylea). The updated treatment approach will allow clinicians, based on individual patients’ outcomes, to lengthen the intervals between injections for patients with neovascular age-related macular degeneration (AMD) who are already in the first year of treatment. That could mean fewer injections and fewer trips to the clinic for patients with AMD.
Approval for the new regimen is based on findings from the phase 4 ALTAIR study1, which tested a so-called “treat-and-extend” approach to AMD at 40 sites in Japan. In the study, 255 patients were given 3 monthly doses of aflibercept, then randomized to either 2-week (n = 124) or 4-week (n = 123) intervals for injections. Intervals could be shortened or lengthened based on clinical factors, and the maximum interval was 16 weeks. Best corrected visual acuity gains were similar between the 2 groups at 52 weeks, with a mean gain of 9.0 letters for the 2-week group and 8.4 letters for the 4-week group.
Said Michael Devoy, MD, chief medical officer of Bayer, “This new treatment regimen for Eylea has the potential to reduce the number of injections and clinic visits to less than 4 in the second year for certain neovascular AMD patients, while still maintaining strong visual outcomes and the ability to see.”
Lower number of injections could also make a difference in costs. Aflibercept is more expensive than its fellow anti-vascular endothelial growth factor treatment bevacizumab, which is routinely used off-label to treat eye disorders. Recent reports have questioned whether aflibercept can compete with bevacizumab in terms of value; one paper from Europe suggested that, for aflibercept to be a justifiable alternative to bevacizumab, aflibercept should be reduced from €943 (approximately $1100) to €533 (approximately $622) per injection.
In addition to pressure to compete on cost, aflibercept is also being targeted by a number of biosimilar developers; Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, and Alteogen has announced that it will file and Investigational New Drug application for its ALT-L9.
Reference
Wai KM, Singh RP. Treat and extend dosing regimen with anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Am J Ophthalmic Clin Trails. 2018;1(1): 1-6. doi: 10.25259/AJOCT-2-2018.
IQVIA Highlights Opportunity to Cash In on Biosimilars for Biologics Losing Market Exclusivity
November 29th 2023A report from IQVIA noted that Europe could miss out on €15 billion in cost savings by not having biosimilars for medications about to lose market exclusivity, shedding light on the implications for overall health care savings and ultimately, patient access.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Pipelines and Preparation: How the US Can Prepare for More RA Biosimilars
April 16th 2023What can practices do to prepare for all the biosimilars to treat rheumatoid arthritis (RA) coming down the pipeline? And how can they ensure that the lower-than-anticipated adoption rates for infliximab biosimilars are not repeated? Robert Zutaut, RPh, from McKesson Provider Solutions, tackles all this and more on this episode of Not So Different.
Study: Biosimilar Use, Dose Rounding Produce More Cost Savings Than Either Strategy Alone
November 18th 2023A retrospective study of New England patients receiving trastuzumab or bevacizumab found that combining dose rounding and biosimilar use resulted in greater cost savings than either strategy alone.
Part 3: Study Questions Usefulness of Clinical Efficacy Trials for Oncology Biosimilars in Europe
November 16th 2023In part 3 of a 3-part series for Global Biosimilars Week, The Center for Biosimilars® reviews an analysis investigating whether clinical efficacy studies have an impact on prescribing decisions for oncology biosimilars across Europe.