| Drug Name |
AHZANTIVE® (aflibercept-mrbb) |
| Active Ingredient |
aflibercept |
| Date of Approval |
June 28, 2024 |
| Manufacturer |
Formycon AG |
| Approval Pathways and Indications |
Approval Pathway: BLA
Indication: AHZANTIVE® is indicated for the treatment of neovascular (wet) age-related macular degeneration(AMD), macular edema following retinal vein occlusion(RVO), diabetic macular edema(DME), and diabetic retinopathy(DR). |
| Therapeutic Class |
A vascular endothelial growth factor (VEGF) inhibitor |
| Formulation |
Injection: 2 mg (0.05 mL of 40 mg/mL) solution 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 |
For AMD, the recommended dose for AHZANTIVE® 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).
For RVO, the recommended dose for AHZANTIVE® is 2 mg (0.05 mL of 40 mg/mL solution) administered by intravitreal injection once every 4 weeks (approximately every 25 days, monthly).
For DME and DR, the recommended dose for AHZANTIVE® 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 5 injections 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, and its prevalence is expected to rise, necessitating updated data for health care planning. A systematic review and meta-analysis of studies since 1996 estimated that 25.3% of individuals 60 years and older have early or intermediate AMD, and 2.4% have late AMD.2 The annual incidence of late AMD is 1.4 per 1000 individuals. By 2050, the number of people with AMD in the European Union is expected to increase from 67 million to 77 million, with late AMD cases rising from 400,000 to 700,000 per year. This growing burden highlights the need for additional health care resources and planning.
AHZANTIVE® is the third biosimilar referencing Eylea for the treatment of eye conditions, including age-related macular degeneration. The approval follows those for Biocon Biologics's Yesafili and Samsung Bioepis' Opuviz, which were approved in May 2024. The cost for Eylea intravitreal solution (40 mg/mL) is around $1,958 for a supply of 0.05 milliliters and the cost for Lucentis intravitreal solution (6 mg/mL) is around $1,242 for a supply of 0.05 milliliters. With the approval of this new biosimilar, there may be more effective, safe and affordable treatment options available 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 safety and efficacy of aflibercept were evaluated in multiple randomized, multi-center, double-masked clinical trials. In patients with wet AMD (VIEW1 and VIEW2), 2412 patients were studied, with the primary endpoint being the proportion maintaining vision (fewer than 15 letters loss in visual acuity) at week 52. Aflibercept 2 mg every 8 weeks (2Q8) and every 4 weeks (2Q4) showed clinical equivalence to ranibizumab 0.5 mg every 4 weeks. Post-week 52, patients continued treatment on a modified 12-week schedule without an active control. In macular edema following CRVO (COPERNICUS and GALILEO), 358 patients were included, and the primary endpoint was the proportion gaining at least 15 letters in BCVA at week 24; aflibercept 2 mg every 4 weeks (2Q4) was superior to sham injections. The VIBRANT study for BRVO involved 181 patients, focusing on the proportion gaining at least 15 letters in BCVA at week 24, where aflibercept 2 mg every 4 weeks (2Q4) outperformed laser photocoagulation. For DME (VIVID and VISTA), 862 patients were evaluated with the primary endpoint being the mean change in BCVA at week 52; both aflibercept regimens (2Q8 and 2Q4) were statistically superior to laser photocoagulation, with sustained benefits at week 100. In diabetic retinopathy (PANORAMA), 402 patients were studied with primary endpoints including a ≥2-step improvement on the ETDRS-DRSS and prevention of proliferative diabetic retinopathy or anterior segment neovascularization at week 52; aflibercept 2Q16 and 2Q8 regimens were superior to sham. Consistent treatment effects were observed across various subgroups (age, gender, race, baseline visual acuity, etc.) in all studies. |
| Sources |
Ahzantive Receives FDA Approval as New Eylea Biosimilar. Center for Biosimilars. https://www.centerforbiosimilars.com/view/ahzantive-receives-
fda-approval-as-new-eylea-biosimilar.
Published June 26, 2024. Accessed July 3, 2024.
Ahzantive (aflibercept-mrbb) injection, for intravitreal use [prescribing information].
FDA. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761378s000lbl.pdf.
Updated June 2024. Accessed July 3, 2024.
Lucentis Prices, Coupons and Patient Assistance Programs. Drugs.com.
https://www.drugs.com/
Accessed July 3, 2024.
Eylea Prices, Coupons and Patient Assistance Programs.
Drugs.com. https://www.drugs.com/price- Accessed July 3, 2024.
FDA Approves Ahzantive (aflibercept-mrbb) Biosimilar to Eylea.
Drugs.com. https://www.drugs.com/newdrugs/fda-approves-ahzantive-aflibercept-mrbb-biosimilar-eylea-6321.html.
Published June 26, 2024. Accessed July 3, 2024.
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