Teva launches Ahzantive aflibercept biosimilar for retinal diseases in Europe

Teva Pharmaceutical Industries has launched AHZANTIVE (aflibercept), an EMA-approved biosimilar to Eylea, in several European markets for adults with neovascular age-related macular degeneration (wet AMD) and other retinal vascular diseases, according to a company announcement.¹ “Biosimilars play a critical role in sustainable healthcare systems,” Yolanda Tibbe, global head of biosimilars at Teva, said in the release. “With this launch, we are expanding our biosimilars portfolio with an important treatment option for people living with serious conditions that can threaten sight.”¹

The prefilled syringe launch began in May 2026 in France, Germany, Spain, and The Netherlands, with additional European markets expected later in the year, the company said.¹ The product was approved by the European Commission in 2025 as a biosimilar to aflibercept reference product Eylea for wet AMD, diabetic macular edema (DME), visual impairment due to myopic choroidal neovascularization, and macular edema following retinal vein occlusion (RVO).^1,2

What does aflibercept biosimilar approval cover?

AHZANTIVE contains aflibercept, a vascular endothelial growth factor (VEGF) inhibitor used by intravitreal administration in retinal diseases characterized by pathologic vascular permeability or neovascularization.² Aflibercept acts as a soluble decoy receptor that binds VEGF-A and related ligands, reducing angiogenic signaling and vascular leakage in the retina.

The EMA describes AHZANTIVE as a biosimilar medicine, meaning it is highly similar to an already authorized biologic reference product in the European Union.² Teva stated that AHZANTIVE demonstrated comparable efficacy, safety, and immunogenicity to Eylea, although the launch announcement did not provide numerical comparative efficacy results, immunogenicity rates, or details of the clinical studies supporting approval.¹

The company’s European commercialization follows a semi-exclusive agreement with Klinge Biopharma GmbH and Formycon AG covering major parts of Europe and Israel.¹ Teva reported that it has 11 biosimilars on the market globally and 13 products in development across oncology, immunology, ophthalmology, and respiratory care; those portfolio figures are company-reported and were not independently detailed in the announcement.¹

How does anti-vegf therapy fit retinal disease care?

The approved indications are chronic, vision-threatening retinal disorders that frequently require repeated intravitreal anti-VEGF treatment. Wet AMD is characterized by choroidal neovascularization under the macula, with leakage, hemorrhage, and progressive central vision loss. DME and RVO-related macular edema involve retinal vascular leakage and swelling that can impair visual acuity, while myopic choroidal neovascularization is a complication of pathologic myopia associated with new vessel growth beneath the retina.²

Aflibercept’s role in retinal disease treatment was established before biosimilar development. In the VIEW 1 and VIEW 2 studies in wet AMD, intravitreal aflibercept regimens were reported to be noninferior to ranibizumab for maintaining vision at 1 year.³ In the VIVID and VISTA trials in DME, aflibercept improved visual outcomes compared with macular laser photocoagulation through 52 weeks.⁴ These trials support the reference molecule’s therapeutic relevance, but biosimilar decisions depend on comparability to the reference product rather than independent demonstration of superiority over existing anti-VEGF options.

The clinical rationale for biosimilars in ophthalmology is largely economic and access-oriented. Anti-VEGF therapy can involve long treatment courses, high injection volume at the health-system level, and recurrent monitoring. Biosimilar competition may reduce acquisition costs and expand formulary options, but the effect on patient-level access will depend on national reimbursement, tendering, physician adoption, and local switching policies.

What questions remain for aflibercept biosimilars?

For clinicians and payers, the main near-term questions are practical rather than mechanistic. The EMA approval indicates regulatory acceptance of biosimilarity to Eylea, but the launch announcement did not include head-to-head numerical outcomes, subgroup analyses by retinal disease, or real-world persistence and switching data.^1,2 These data may be relevant in ophthalmology, where small differences in injection burden, inflammation rates, device usability, or supply reliability can affect treatment programs.

Safety monitoring will also be important as use broadens. Teva reported comparable safety and immunogenicity to the reference product, and the EMA product information identifies AHZANTIVE as a biosimilar to Eylea.^1,2 However, rare intraocular inflammatory events, endophthalmitis, and vascular events are generally best characterized through larger postmarketing exposure than through preapproval comparability studies alone.

The launch adds another aflibercept biosimilar option to European retinal disease care, but its clinical impact will likely be measured less by differentiated efficacy than by uptake, cost effects, continuity of supply, and confidence among retina specialists in biosimilar substitution or switching frameworks.

References

1. Teva expands European biosimilars portfolio with launch of AHZANTIVE® (aflibercept) biosimilar to Eylea®. (2026 Jun 4). GlobeNewswire. https://www.globenewswire.com/news-release/2026/06/04/3306757/0/en/teva-expands-european-biosimilars-portfolio-with-launch-of-ahzantive-aflibercept-biosimilar-to-eylea.html
2. Ahzantive: European public assessment report. (2026 Jun4). European Medicines Agency. https://www.ema.europa.eu/en/medicines/human/EPAR/ahzantive
3. Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF Trap-Eye) in wet age-related macular degeneration. (2012 Dec). Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/23084240/
4. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. (2014 Nov). Intravitreal aflibercept for diabetic macular edema. Ophthalmology. https://pubmed.ncbi.nlm.nih.gov/25012934/