In a review, investigators focused on ranibizumab (Lucentis; Genentech), aflibercept (Eylea; Regeneron), and bevacizumab (Avastin; Genentech) as growth opportunities in the biosimilar space.
According to the 2024 Biosimilar Report: Insights on a Pivotal Year of Evolution and Expansion, 2024 is expected to be a big year for retina biosimilars.1
In an interview with Pharmacy Times, Fran Gregory, PharmD, MBA, vice president of Emerging Therapies at Cardinal Health, said, “Our research was really focused on the area of retina specialists, with a lot of buzz and a lot of opportunity for cost savings in the retina space with Eylea, Avastin, and Lucentis biosimilars.”1
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According to a review published in Survey of Ophthalmology, these anti-vascular endothelial growth factors (VEGF) biologics are essential for treatment of many retina-based diseases. However, the review authors stated that high costs of branded biologics have posed barriers for patients, limiting access to treatment and resulting in poorer clinical outcomes for some patients. Biosimilars in many therapeutic spaces have been introduced to help mitigate the financial burden and hopefully improve compliance and outcomes, according to the authors of the review.2
The authors aimed to provide an overview of the development of biosimilars in ophthalmology, focusing on anti-VEGF biosimilars. The authors focus on 3 primary drugs: ranibizumab (Lucentis; Genentech), aflibercept (Eylea; Regeneron), and bevacizumab (Avastin; Genentech), which are expected to see the most growth in the coming years.1,2
Biosimilars for the treatment of ophthalmic diseases first became available with the approval of SB11 (Byooviz; Samsung Bioepis), a ranibizumab biosimilar, in 2021, according to the study authors. Since then, additional ranibizumab biosimilars have been introduced, including FYB201 (ranibizumab-eqrn, Cimerli; Coherus Biosciences), which is approved in the United States, and XSB-001, which was submitted for regulatory approval in April 2023.2
Additionally, there are 2 aflibercept biosimilars in the pipeline: MYL-1701 P (Biocon Biologics and Momenta Pharmaceuticals) and ABP 938 (Amgen). MYL-1701 P was submitted to the FDA in October 2021 and ABP 938 completed a phase 3 trial in January 2023, but the results have not yet been published, according to the review authors. The FDA has also accepted a biologics license application for ABP 938. According to an article from Ophthalmology Times, the exclusivity for 2 mg of Eylea expires on May 17, 2024.2,3
Furthermore, there are 2 key biosimilars being investigated for bevacizumab, according to the review authors. ONS-5010 (bevacizumab-vikg, Lytenava, Outlook Therapeutics) has been accepted by the FDA as treatment for neovascular age-related macular degeneration (nAMD) in the United States. If approved, it would prohibit compounding pharmacies from creating compounds of bevacizumab, which has been used off-label under Section 503a of the Federal Food, Drug, and Cosmetic Act. HLX04 (Shanghai Henlius Biotech), which has been approved for the treatment of gastrointestinal and pulmonary malignancies in China, is currently being investigated for nAMD in the United States. Trials are expected to be completed by August 2024, according to the review authors.2
According to the review authors, the successful adoption of ophthalmic biosimilars will depend on continuous education for stakeholders regarding biosimilars and their associated benefits.2
