In the United States, two ranibizumab biosimilars (Byooviz, Samsung Bioepis; Cimerli, Coherus Biosciences) have been approved for the treatment of neovascular age-related macular degeneration (AMD), and more are in the pipeline, along with aflibercept and bevacizumab biosimilars.
The issue of cost. In retina, all biosimilars hold the promise of providing effective treatment for AMD and other retinal diseases at a lower cost than the original reference drug—a significant consideration now that aflibercept and ranibizumab are among the top few drugs, in terms of costs, of all drugs covered under Medicare Part B.
At Friday’s Retina Subspecialty Day, Susan B. Bressler, MD, noted that the development of originator biologics requires extensive investment of time and money to establish efficacy and safety via clinical studies. In contrast, with biosimilars, the intense period occurs “in the design specification of the molecule,” with less effort required during the validation phase.
Recent research on aflibercept biosimilar. Dr. Bressler presented findings from a phase 3 study comparing the aflibercept biosimilar SB15 (Samsung Bioepis) to aflibercept. In an earlier analysis, the two agents demonstrated equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity at 32 weeks.1
For the second phase of the study, at week 32, those treated with aflibercept were randomly assigned to either continue with aflibercept (n = 104) or be switched to SB15 (n = 111). At 56 weeks, Dr. Bressler reported, both VA and OCT outcomes appeared to be maintained in those who were switched from Eylea to SB15. Moreover, she said, “no new safety signals emerged.” The results provide “additional confidence that switching from a reference product to a biosimilar maintains safety and efficacy of therapy.”
A note on reimbursement. Also at Retina Subspecialty Day, Ankoor R. Shah, MD, noted that Q codes are used for biosimilars and will become more common as more of these agents enter the market.
But whether the drug is a reference agent or a newly approved biosimilar, he noted, “You really need to have a systematic approach for how to deal with reimbursement.” He suggested a comprehensive approach that includes starting with the easiest cases first, being prepared for appeals, and continuously monitoring payer policies.
For more information on reimbursement, Academy and AAOE members can see the following articles: “How to Add a New Retina Drug to Your Practice” (EyeNet, July 2023) and “Geographic Atrophy–How to Get Paid for New Treatments” (EyeNet, November 2023).
—Jean Shaw
1 Woo SJ et al. JAMA Ophthalmol. 2023;141(7):668-676.
Financial disclosures: Dr. Bressler: Amgen: C; Bayer Healthcare Pharmaceuticals: S; Biocon: S; Biogen: S; Boehringer Ingelheim: S; EyePoint: S; Genentech: S; Merck: S; Mylan: S; Notal Vision: S; Novartis/Alcon: S; Regeneron: S. Dr. Shah: Apellis: US; Notal Vision: C; Regeneron: C; Regenxbio: C.
Disclosure key: C = Consultant/Advisor; E = Employee; EE = Employee, executive role; EO = Owner of company; I = Independent contractor; L = Lecture fees/Speakers bureau; P = Patents/Royalty; PS = Equity/Stock holder, private corporation; S = Grant support; SO = Stock options, public or private corporation; US = Equity/Stock holder, public corporation For definitions of each category, see aao.org/eyenet/disclosures.
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