The 2024 surge in FDA approvals for aflibercept biosimilars reflects significant progress in offering cost-effective treatments for retinal conditions like neovascular age-related macular degeneration, although patent disputes pose challenges to their market entry and adoption.
The 2024 advancements in ophthalmology biosimilars marked a transformative phase for aflibercept alternatives, with multiple FDA approvals signaling expanded treatment options for retinal conditions. Interchangeability designations and robust clinical data emphasized the potential for improved access, cost savings, and healthcare innovation. However, ongoing patent disputes underscore the complexities of bringing these promising therapies to market.
Here are the top 5 ophthalmology biosimilar articles for 2024.
5. SB15 Effective, Safe in Treating nAMD Before, After Switching
A multiregion phase 3 study demonstrated that SB15, a biosimilar to Eylea (aflibercept), showed comparable efficacy, safety, immunogenicity, and pharmacokinetics in treating neovascular age-related macular degeneration (nAMD), both as a first-line therapy and after switching from the originator. Across 56 weeks, changes in visual acuity, retinal thickness, and choroidal neovascularization were minimal, with treatment-emergent adverse events being mild or moderate and similar across groups. The findings support the safety and effectiveness of switching patients from reference aflibercept to SB15.
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4. FDA Approves Biosimilar Enzeevu for Eye Conditions
Sandoz's Enzeevu (aflibercept-abzv) has become the fourth FDA-approved biosimilar referencing Eylea and includes interchangeability, enabling substitution at the pharmacy level without provider consent. Approved for treating nAMD, Enzeevu demonstrated comparable efficacy, safety, and pharmacokinetics to the reference product in a phase 3 study, with no significant differences in vision improvement or adverse events. This approval represents greater hope for more cost-effective options for managing nAMD, a leading cause of vision impairment.
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3. Ahzantive Receives FDA Approval as New Eylea Biosimilar
Formycon and its licensing partner Klinge Biopharma secured FDA approval for Ahzantive (aflibercept-mrbb), marking it as the third biosimilar referencing Eylea to receive approval. This milestone builds on prior approvals for Biocon Biologics' Yesafili and Samsung Bioepis' Opuviz earlier in 2024. The approval was based on robust data from the MAGELLAN-AMD phase 3 study, which demonstrated that Ahzantive's safety, efficacy, and tolerability were comparable to Eylea, with no new safety signals identified.
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2. FDA Approves Pavblu for Retinal Conditions
The FDA has approved Pavblu (aflibercept-ayyh), developed by Amgen, as the fifth biosimilar referencing Eylea to treat retinal conditions like nAMD and diabetic retinopathy. Clinical trials demonstrated Pavblu’s comparable safety and efficacy to Eylea, reinforcing its biosimilarity. Meanwhile, Amgen faces a legal challenge from Regeneron over patent infringement related to Pavblu’s development, with a court decision pending.
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1. FDA Approves First Eylea Biosimilars
The FDA has approved the first 2 biosimilars referencing Eylea: Yesafili (Biocon Biologics) and Opuviz (Samsung Bioepis), both VEGF inhibitors for treating conditions like nAMD and diabetic retinopathy. These biosimilars received interchangeability designations, too, enabling pharmacy-level substitution without physician approval, improving patient access and addressing drug shortages. However, their market entry may face delays due to ongoing patent litigation with Eylea’s maker, Regeneron.
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Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
A Banner Year for Biosimilars: The 19 FDA Approvals From 2024
January 21st 2025In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab and denosumab, marking significant progress in expanding treatment options and market competition.
Study Confirms CT-P42 Therapeutic Equivalence to Reference Aflibercept in DME
January 6th 2025The phase 3 trial showed biosimilar CT-P42 (Celltrion) is therapeutically equivalent to reference aflibercept in improving visual acuity in patients with diabetic macular edema (DME), with comparable efficacy, safety, pharmacokinetics, and immunogenicity at 24 weeks, with more long-term data expected.
Cost and Efficacy Insights on Infliximab Biosimilars in Pediatric Uveitis
December 3rd 2024The study highlights the safety, efficacy, and cost benefits of infliximab biosimilars in managing pediatric noninfectious uveitis, showing fewer disease flares and reduced costs compared with reference infliximab, as well as the influence of insurance mandates on treatment decisions.