Samsung Bioepsis' SB15 was comparable to Eylea (aflibercept) in a 56-week randomized clinical trial that included a rerandomization at 32 weeks. The rerandomization resulted in 111 study volunteers switching from Eylea to the biosimilar for the last part of the study.
A switching study of biosimilar to Eylea (aflibercept) showed no loss of efficacy or increase in side effects, according to results reported today at the American Society of Retinal Specialists (ASRS) annual scientific meeting in Seattle.
Samsung Bioepis, a Korean company and a major developer of biosimilars of drugs for other conditions, has been putting out positive results about its Eylea biosimilar, which is going by the name SB15 for now. Researchers reported favorable results for SB15 at the Association for Research in Vision and Ophthalmology annual meeting in April. Se Joon Woo, M.D., Ph.D., an assistant professor at the Seoul National University Bundang Hospital in Korea and the principal investigator of the phase 3 trial comparing SB15 to Eylea, was the lead author of a report published online in JAMA Ophthalmology in June that showed SB15 was comparable to Eylea after eight weeks on the best-corrected visual acuity measurement that is often used in ophthalmology trials.
Favorable results from switching studies can be used to apply for interchangeability designation from the FDA, which makes it easier to switch patients to biosimilar and may also persuade some wary physicians — in this case retinal specialists — that the biosimilar is just as safe and effective as the biosimilar.
Min Sagong, M.D., Ph.D., of Yeungnam University College of Medicine and coauthor of the JAMA Ophthalmology paper, reported the results of the SB15-Eylea comparison study through 56 weeks, today at ASRS.
The 449 patients enrolled in the trial were initially randomized to either receive three, 2 mg injections of SB15 or Eylea every 4 weeks and then injections every eight weeks through 48 weeks. The study participants were then rerandomized after 32 weeks, so 219 continued to be treated with SBS15, 108 stayed on Eylea and 111 switched from Eylea to SB15.
Sagong reported that improvements in best-corrected visual acuity was comparable between the treatment groups, including in a comparison between those who stayed on Eylea and those randomized to switch from the brand-name product to biosimilar.
The same was true of anatomical outcomes and the safety and the immunogenicity. The researchers also found neither new intraocular inflammation or antidrug antibodies in the Eylea-to-SB15 switching group.
“Switching from AFL (aflibercept) to SB15 had no treatment-emergent issues such as loss of efficacy, increased adverse events, or increased immunogenicity,” the abstract of the Sagong’s presentation concluded.