Regulatory Decision Summary for Aflivu

The purpose of this new drug submission (NDS) was to seek market authorization of Aflivu (aflibercept injection), as a biosimilar to Eylea, for the treatment of neovascular (wet) age-related macular degeneration (AMD); diabetic macular edema (DME), visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO) and myopic choroidal neovascularization (myopic CNV).

The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.

Aflibercept contains the same active pharmaceutical ingredient, aflibercept, as the Canadian authorized reference product Eylea. The clinical evidence for this NDS came from a randomised, controlled, double-masked study comparing the efficacy, safety, clinical pharmacology and immunogenicity of Aflivu and Eylea in patients with wet AMD. A total of 576 patients with wet AMD received either Aflivu (n = 288) or Eylea (n = 288) into the studied eye via intravitreal (IVT) route every 4 weeks for the first 3 injections and every 8 weeks thereafter until Week 48. The primary efficacy endpoint was the change from baseline in best-corrected visual acuity (BCVA) at Week 8.

The results from the clinical study demonstrated that no clinically meaningful differences in efficacy, safety, exposure and immunogenicity were observed between Aflivu and Eylea in patients with wet AMD. Extrapolation to other sought indications, i.e., DME, CRVO, BRVO and myopic CNV is based on adequate justifications, e.g., similar efficacy and safety profiles between SCD411 and Eylea in wet AMD population, the same mechanism of action of aflibercept, consistent safety profiles across the indications currently authorized for Eylea.

The proposed dose regimens of Aflivu are the same as those for Eylea.

The final recommendation for this product was based on the totality of evidence, including structural, functional comparability, non-clinical data and clinical similarity in efficacy, safety, pharmacokinetics and immunogenicity between Aflivu and Eylea.

Overall, the benefit/risk profile of Aflivu was found similar to that of Eylea and it is therefore considered favorable for all the indications sought in adults (i.e., wet AMD, DME, CRVO, BRVO and myopic CNV).

An updated Risk Management Plan (RMP) for Aflivu was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Aflivu has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Aflivu, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.