FDA Approves Biosimilar Enzeevu for Eye Conditions

Sandoz secured another approval, this time for an aflibercept biosimilar.¹ Enzeevu (aflibercept-abzv) is the fourth biosimilar referencing Eylea and is approved to treat neovascular age-related macular degeneration (nAMD) and was granted interchangeability, allowing it to be substituted in place of the reference product at the pharmacy level without provider permission.

“nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease,” commented Claire D’Abreu-Hayling, chief scientific officer, Sandoz.

The approval follows those 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. The approval also comes after Sandoz's acquisition of the Cimerli (ranibizumab-eqrn) business in the US earlier in 2024. The acquisition, which included field force employees, enhanced Sandoz's leading ophthalmology portfolio in the US and established a solid foundation for the upcoming launch of Enzeevu.⁴

Aflibercept products are vascular endothelial growth factor inhibitors, which are administered intravitreally in a physician’s office. When treating eye conditions, anti-VEGF medicines stop the abnormal blood vessels leaking, growing and then bleeding under the retina, which can cause intense pain and vision loss for patients.⁵

The approval was based on a comprehensive data package, including data from the phase 3 Mylight study comparing the safety and efficacy of Enzeevu with that of Eylea.⁶ The prospective, double-masked, 2-arm, parallel study randomized patients 1:1 to receive 8 injections of the biosimilar (n = 244) or reference product (n = 240) over 48 weeks. The primary end point was mean change in best corrected visual acuity (BCVA) score from baseline to week 8. Secondary end points 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 at week 52. No clinically significant differences were observed in anatomical outcomes between the groups. Safety profiles were comparable, with similar rates of treatment-related adverse events (biosimilar vs originator, 2.5% vs 2.9%). The incidence of antidrug antibodies was also similar across both groups. Systemic free aflibercept concentrations 24 hours post dose were low and comparable between the 2 products.

Jeff Todd, JD, president and CEO of Prevent Blindness, celebrated the approval, saying, “As sight disappears, so may a person’s connection to the world. We welcome all treatment options that help maintain vision and meet the unique needs of the individual so those living with wet AMD can potentially maintain their independence longer. At this time, there is no cure for this disease and long-term treatment can be costly. Having more FDA-approved options, including biosimilars, can help make health care more person centered and affordable.”¹

References

1. Sandoz receives FDA approval for Enzeevu (aflibercept-abzv), further strengthening US biosimilar position. News 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 approved first Eylea biosimilars. The Center for Biosimilars®. May 20, 2024. Accessed August 12, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars

3. Jeremias S. Ahzantive receives FDA approval as new Eylea biosimilar. The Center for Biosimilars. July 1, 2024. Accessed 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 August 12, 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 biosimilar aflibercept, SDZ-AFL, in patients with neovascular age-related macular degeneration: 52-week results from the Phase 3 Mylight study. RETINA-J Ret Vit Dis. Published online June 4, 2024. doi:10.1097/IAE.0000000000004174