FDA approves biosimilar drug Enzeevu for eye diseases

Sandoz has been granted another approval, this time for a biosimilar of aflibercept.1 Enzeevu (aflibercept-abzv) is the fourth biosimilar to reference Eylea and is approved to treat neovascular age-related macular degeneration (nAMD) and has been granted interchangeability, allowing it to be substituted for the reference product at the pharmacy level without supplier authorization.

Neovascular AMD, or wet AMD, remains a leading cause of vision impairment in patients over the age of 50 in North America. The disease affects millions of people, causing significant challenges in their daily lives due to the progressive loss of central vision. The approval of Enzeevu in the U.S. is a key milestone in Sandoz’s efforts to significantly improve the lives of patients affected by this incurable disease, said Claire D’Abreu-Hayling, Sandoz’s Chief Scientific Officer.

This approval follows approvals for Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) in May 2024 and Ahzantive (aflibercept-mrbb) in July 2024.2,3 Yesafili and Opuviz were also approved with interchangeability. This approval also follows Sandoz’s acquisition of the Cimerli (ranibizumab-eqrn) business in the U.S. earlier in 2024. This acquisition, which included field employees, strengthened Sandoz’s leading U.S. ophthalmic portfolio and established a strong foundation for the upcoming launch of Enzeevu.4

Aflibercept products are vascular endothelial growth factor inhibitors, which are administered intravitreally in a doctor's office. When treating eye conditions, anti-VEGF drugs stop the leakage, growth, and bleeding of abnormal blood vessels under the retina, which can cause severe pain and vision loss in patients.5

The approval is supported by a comprehensive set of data, including data from the Phase 3 Mylight study comparing the safety and efficacy of Enzeevu to Eylea.6 The prospective, double-blind, two-arm, parallel study randomized patients 1:1 to receive 8 injections of the biosimilar (n=244) or the reference product (n=240) over 48 weeks. The primary endpoint was mean change in best-corrected visual acuity (BCVA) score from baseline to week 8. Secondary endpoints included BCVA at weeks 24 and 52, as well as pharmacokinetics.

The mean change in BCVA score was similar between the biosimilar (n = 235) and the reference product (n = 226) at week 8 (difference, 0.3; 90% CI, 1.5 to 1.0) and week 52. No clinically meaningful differences in anatomic outcomes were observed between groups. Safety profiles were comparable, with similar rates of treatment-related adverse events (biosimilar vs. originator, 2.5% vs. 2.9%). The incidence of anti-drug antibodies was also similar in the two groups. Systemic concentrations of free aflibercept 24 hours after the dose were low and comparable between the 2 products.

Jeff Todd, JD, President and CEO of Prevent Blindness, welcomed the approval, saying, “As sight fades, a person’s connection to the world can fade as well. We welcome all treatment options that help preserve vision and address the unique needs of each individual so that people with wet AMD can potentially maintain their independence longer. Currently, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make healthcare more person-centered and affordable.1

References

1. Sandoz Receives FDA Approval for Enzeevu (aflibercept-abzv), Strengthening U.S. Position as Biosimilar. Press Release. Sandoz. August 12, 2024. Accessed August 12, 2024. https://www.sandoz.com/sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar/

2. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Retrieved August 12, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars

3. Jeremias S. Ahzantive receives FDA approval as new biosimilar to Eylea. The Center for Biosimilars. July 1, 2024. Retrieved August 12, 2024. https://www.centerforbiosimilars.com/view/ahzantive-receives-fda-approval-as-new-eylea-biosimilar

4. Jeremias S. Eye on pharma: Coherus offloads Cimerli; Celltrion files for CT-P47; Alvotech shares denosumab results. The Center for Biosimilars. January 30, 2024. Accessed August 12, 2024. https://www.centerforbiosimilars.com/view/eye-on-pharma-coherus-offloads-cimerli-celltrion-files-for-ct-p47-alvotech-shares-denosumab-results

5. Anti-VEGF intravitreal injection treatment. Moorfields Eye Hospital. Accessed 12 August 2024. https://www.moorfields.nhs.uk/mediaLocal/fmincyp1/anti-vegf-intravitreal-injection-treatment.pdf

6. Bordon AF, Kaiser PK, Wolf A, et al. Efficacy and safety of the proposed aflibercept biosimilar, SDZ-AFL, in patients with neovascular age-related macular degeneration: 52-week results from the Mylight phase 3 study. RETINA-JRet Vit Dis. Published online June 4, 2024. doi:10.1097/IAE.0000000000004174

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