Intas Pharma Receives CDSCO Panel Nod for Aflibercept Biosimilar DME Trial

Key Insights

• Intas Pharmaceuticals gains CDSCO approval for a Phase III trial comparing its aflibercept biosimilar with Eylea in diabetic macular edema (DME) patients.
• The study will evaluate the efficacy, safety, and immunogenicity of Intas' aflibercept intravitreal injection against Eylea.
• CDSCO's approval is contingent upon refined inclusion criteria, a minimum of 100 evaluable subjects in the test arm, and specific patient management protocols.

Intas Pharmaceuticals has received the green light from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to proceed with a Phase III clinical trial evaluating its aflibercept biosimilar in patients with Diabetic Macular Edema (DME). The proposed study aims to compare the efficacy, safety, and immunogenicity of Intas' aflibercept intravitreal injection with Eylea (aflibercept) intravitreal injection. This approval is subject to specific conditions outlined by the CDSCO panel.

The trial, described as a "Phase-3, Double-Masked, Two-Arm, Multiple Dose, Parallel Group, Randomized, Multicentre, Active-Controlled, Comparative Clinical Study," will adhere to Protocol 0252-24 Version: 1.0, dated 11.07.2024. Aflibercept functions as a vascular endothelial growth factor (VEGF) inhibitor and is used in treating neovascular (wet) age-related macular degeneration (AMD), various macular edema types, diabetic retinopathy, and metastatic colorectal cancer.

CDSCO Recommendations

During the SEC meeting for ophthalmology on November 21, 2024, the expert panel carefully reviewed the trial proposal. Following deliberation, the committee recommended the Phase III study proceed, provided Intas adheres to several key conditions:

1. Inclusion Criteria Refinement: The protocol must clearly define acceptable fasting and postprandial blood sugar levels within the inclusion criteria to ensure a well-defined patient population.
2. Sample Size: The test arm must include a minimum of 100 evaluable subjects to provide sufficient statistical power for meaningful comparisons.
3. Patient Safety: The protocol should specify that subjects be discontinued from the study if any worsening condition or adverse event occurs in the treatment eye. Furthermore, these patients should receive standard of care treatment.
4. Fellow Eye Management: The trial protocol must incorporate provisions for the treatment of the other eye according to the standard of care.

The SEC has requested that Intas Pharmaceuticals submit a revised protocol incorporating these recommendations to the CDSCO for further evaluation. This rigorous review process underscores the regulatory body's commitment to ensuring patient safety and data integrity in clinical trials for biosimilar products.