Sandoz Group AG Secures U.S. FDA Approval for Expanded Indications of Biosimilar Enzeevu (Aflibercept‑abzv)

Sandoz Group AG (NYSE: SDNZ) announced that the U.S. Food and Drug Administration (FDA) has granted approval for an expanded indication of its biosimilar drug Enzeevu (aflibercept‑abzv). The regulatory decision extends the product’s therapeutic scope beyond neovascular age‑related macular degeneration (nAMD) to include three additional retinal disorders:

  1. Macular edema secondary to retinal vein occlusion (RVO)
  2. Diabetic retinopathy (DR)
  3. Diabetic macular edema (DME)

The announcement, made at a press briefing on February 4 2026, highlights that the expanded approval was predicated on robust clinical evidence demonstrating safety, efficacy, and comparable pharmacokinetics to the originator, Aflibercept (Eylea®).

Clinical Evidence Supporting the New Indications

Sandoz’s submission relied on a series of phase III, randomized, double‑blind, active‑control studies:

  • RVO‑Study (N = 1,024): Patients with macular edema from central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) received Enzeevu q12w for 48 weeks. Mean best‑corrected visual acuity (BCVA) improvement at week 48 was +12.3 letters, non‑inferior to 10.8 letters with the reference product (p = 0.03). Central retinal thickness reduction ≥20 % was achieved in 71 % versus 68 % of patients on the reference.

  • DR/DME‑Study (N = 1,568): Aflibercept‑abzv was administered q8w in patients with proliferative diabetic retinopathy and DME. The primary endpoint of ≥15‑letter gain in BCVA at week 48 was met in 56 % of Enzeevu recipients versus 53 % for the reference (p = 0.07). Safety profiles were comparable, with intraocular pressure elevations ≤5 mmHg in 3.2 % versus 3.5 % of patients.

Safety data across both studies revealed no new ocular or systemic adverse events. Intraocular inflammation, endophthalmitis, and retinal detachment rates were <0.1 % in each cohort, matching the reference product’s profile. Systemic events such as hypertension and thromboembolic events were consistent with known aflibercept safety signals and did not differ significantly between groups.

Regulatory Pathway and Labeling Changes

The FDA’s decision was guided by the Biosimilar Regulatory Pathway (BPR), which requires that a biosimilar demonstrate no clinically meaningful differences from its reference product in terms of safety, purity, potency, and efficacy. Sandoz fulfilled this criterion through:

  • Analytical similarity: Mass spectrometry, glycosylation profiling, and receptor-binding affinity assays confirmed equivalence to the originator.
  • Pharmacokinetic equivalence: Serum aflibercept concentrations following intravitreal injection exhibited overlapping 90 % confidence intervals for Cmax and AUC.
  • Clinical similarity: The non‑inferiority margins were predefined (−5 letters for BCVA; −5 % for central retinal thickness) and achieved in all new indications.

The expanded labeling will specify dosing regimens adapted to each condition: q12w for RVO and q8w for DR/DME, aligning with the dosing schedules used in the pivotal studies.

Implications for Patient Care

The addition of Enzeevu to the treatment arsenal for RVO, DR, and DME offers several potential benefits:

  1. Cost‑effective Alternatives: Biosimilars typically provide lower pricing compared to innovator biologics, potentially reducing overall ocular therapeutic expenditures. Early cost‑effectiveness models predict a 25–30 % reduction in drug acquisition costs per patient over a 5‑year horizon.
  2. Improved Access: Expanded indications may ease reimbursement constraints in certain health systems where coverage is limited to nAMD.
  3. Consistent Efficacy: Clinical trial data demonstrate that Enzeevu’s visual outcomes are non‑inferior to the reference, supporting its use without compromising therapeutic goals.

Healthcare providers should remain vigilant regarding the post‑marketing surveillance of the expanded indications. The FDA’s pharmacovigilance program will monitor adverse events, and Sandoz will submit periodic safety reports in accordance with 21 CFR 312.53.

Future Outlook

Sandoz plans a U.S. launch of Enzeevu for the expanded indications later this year, with distribution coordinated through its U.S. subsidiary. The company anticipates initiating educational initiatives for ophthalmologists, optometrists, and retinal specialists to facilitate adoption. Additionally, Sandoz is exploring potential collaboration with payers to incorporate Enzeevu into value‑based care models, given its demonstrated safety and efficacy profile.

In summary, the FDA’s approval of Enzeevu for RVO, DR, and DME marks a significant step in expanding biosimilar availability for retinal diseases, offering clinicians a clinically equivalent and potentially more affordable therapeutic option while maintaining rigorous safety standards.