Anti–vascular Endothelial Growth Factor Biosimilars in Ophthalmology

Abstract

Statement: Anti–vascular endothelial growth factor biosimilars in ophthalmology are expected to enter the United States and European markets in the coming years. This review discusses the biosimilar approval process and presents the currently approved and upcoming biosimilars in ophthalmology.

Biosimilars for Retinal Diseases: A Review of the Literature

“…Ranibizumab-eqrn (FYB201) (Cimerli; Formycon) was the second intraocular biosimilar to be FDA-approved in August 2022. 12 It is unique in that it was granted interchangeability status for ranibizumab's 5 approved indications (nAMD, DME, DR, macular edema following RVO, and Myopic choroidal neovascularization), in contrast to SB11 which is only approved for 3 of these indications. 40 Interchangeability allows ranibizumab-eqrn to be automatically substituted at the pharmacy, subject to state law, similar to how generic drugs are handled.…”

“…FDA approval of the biosimilar relies on demonstrating equivalence of the biosimilar to its reference 10 . The biosimilar must undergo analytical testing to confirm structural and chemical comparability to the reference biologic, animal testing to determine toxicity, and a phase III clinical trial 10,12,19 . Biosimilars can only reach the market following the expiration of their reference’s patent, 21,22 though pharmaceutical companies are not required to divulge their product’s development process at any timepoint 11,23 …”

“…10 The biosimilar must undergo analytical testing to confirm structural and chemical comparability to the reference biologic, animal testing to determine toxicity, and a phase III clinical trial. 10,12,19 Biosimilars can only reach the market following the expiration of their reference's patent, 21,22 though pharmaceutical companies are not required to divulge their product's development process at any timepoint. 11,23 Biosimilars and their references share similar safety and efficacy profiles, differing primarily in their clinical trial and market delivery processes.…”

“…28,29 If all of these steps are successful in affirming equivalence between the 2 therapeutics, a governing body typically approves the biosimilar for clinical use for all indications of the reference biologic. 12 Despite their similarity, biosimilars and biologics are not automatically considered interchangeable. To become interchangeable, biosimilars must undergo supplemental studies that demonstrate either equivalent or decreased safety and efficacy risk when switching to the biosimilar from the reference biologic.…”

“…Based on available data, novel drugs on average require 10 to 15 years and $1.2 billion to $2.5 billion to develop, while biosimilars conversely require 8 to 10 years and $100 million to $200 million 11 . Between 2016 and 2022, the European Union saved $11.8 billion from using biosimilars instead of biologics, 12 and the United States is estimated to save $44 billion by using biosimilars from 2017 to 2026 13 . Other specialties have shown substantial benefits from biosimilars in terms of clinical outcomes, with fewer financial barriers leading to increased health care accessibility and better treatment compliance 14–17 …”