| Drug Name |
ENZEEVU™(aflibercept-abzv) |
| Active Ingredient |
aflibercept |
| Date of Approval |
August 9th, 2024 |
| Manufacturer |
Sandoz Inc. |
| Approval Pathways and Indications |
Approval Pathway: BLA
Indication: ENZEEVU™ is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD) |
| Therapeutic Class |
VEGF inhibitor |
| Formulation |
Injection: 2 mg (0.05 mL of 40 mg/mL) solution in a single-dose pre-filled syringe and in a single-dose vial |
| MoA |
Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF) are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability. Aflibercept products act as soluble decoy receptors that bind VEGF-A and PlGF, and thereby can inhibit the binding and activation of these cognate VEGF receptors. |
| Dosing and Administration |
The recommended dose for ENZEEVU™ is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days, monthly) for the first 3 months, followed by 2 mg (0.05 mL of 40 mg/mL solution) via intravitreal injection once every 8 weeks (2 months) |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
Neovascular (Wet) Age-Related Macular Degeneration is the leading cause of visual impairment and blindness in Europe, with its prevalence expected to rise. A systematic review since 1996 found that 25.3% of those aged 60 and older have early or intermediate AMD, and 2.4% have late AMD. The annual incidence of late AMD is 1.4 per 1,000 individuals. By 2050, the number of people with AMD in the EU is expected to grow from 67 million to 77 million, with late AMD cases rising from 400,000 to 700,000 annually, stressing the need for enhanced health care planning.
ENZEEVU™ is the fourth biosimilar referencing Eylea for treating eye conditions, including AMD, following the approvals of Ahzantive, Yesafili, and Opuviz in 2024. Eylea's intravitreal solution costs around $1,958 per 0.05 milliliters, while Lucentis costs around $1,242 for the same amount. The approval of ENZEEVU™ may offer more effective, safe, and affordable treatment options for retinal diseases. |
| Expected Market Launch Date |
Data Unavailable |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Data Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
The approval of ENZEEVU™ was based on a comprehensive data package, including results from the phase 3 Mylight study, which compared the safety and efficacy of ENZEEVU™ to Eylea. This was a prospective, double-masked, 2-arm, parallel study that randomized patients in a 1:1 ratio to receive 8 injections of either the biosimilar (n = 244) or the reference product (n = 240) over a period of 48 weeks. The primary endpoint was the 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, with a difference of –0.3 (90% CI, –1.5 to 1.0), and remained similar at week 52. There were no clinically significant differences in anatomical outcomes between the two groups. The safety profiles were comparable, with similar rates of treatment-related adverse events reported (biosimilar vs. originator, 2.5% vs. 2.9%). Additionally, the incidence of antidrug antibodies was similar across both groups. Systemic free aflibercept concentrations measured 24 hours post-dose were low and comparable between the two products. |
| Sources |
Sandoz Inc. ENZEEVU (aflibercept-abzv) Prescribing Information. Available at: https://prod.cms.us.sandoz.com/sites/
spare37_sandoz_com/files/Media%20Documents/ENZEEVU_PI_2024_2.pdf. Accessed August 13, 2024.
BioSpace. Sandoz Receives FDA Approval for ENZEEVU (Aflibercept-abzv), Further Strengthening US Biosimilar Position. Available at: https://www.biospace.com/
sandoz-receives-fda-approval-for-enzeevu-aflibercept-abzv
-further-strengthening-us-biosimilar-position. Accessed August 13, 2024.
GlobeNewswire. Sandoz Inc. Receives FDA Approval for ENZEEVU (aflibercept-abzv).
Available at: https://ml-eu.globenewswire.com
/Resource/Download/5e42e66a-aa56-4202-ab0c-12c4340e6bfc.
Accessed August 13, 2024.
The Center for Biosimilars. FDA Approves Biosimilar ENZEEVU for Eye Conditions. Available at: https://www.centerforbiosimilars.com
/view/fda-approves-biosimilar-enzeevu-for-eye-conditions.
Accessed August 13, 2024.
Lucentis Prices, Coupons and Patient Assistance Programs.
Drugs.com. https://www.drugs.com/price-guide
/lucentis#:~:text=The%20cost%20for%20 Lucentis%20 intravitreal,not%20valid%20with%20insurance%20plans.
Accessed August 13, 2024.
Eylea Prices, Coupons and Patient Assistance Programs. Drugs.com.
https://www.drugs.com/
price-guide/eylea#:~:text=
The%20cost%20for%20Eylea%20intravitreal,
not%20valid%20 with%20insurance%20 plans.
Accessed August 13, 2024.
|