Regulatory Decision Summary for Pavblu

The purpose of this new drug submission (NDS) was to seek market authorization of the biosimilar biologic drug, Pavblu (aflibercept injection), for use in the treatment of neovascular (wet) age-related macular degeneration (AMD), 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), treatment of diabetic macular edema (DME), and treatment of myopic choroidal neovascularization (CNV).

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

Pavblu is a biosimilar drug that contains the same active pharmaceutical ingredient aflibercept as the Canadian authorized reference biologic drug Eylea. Comparative qualitative studies demonstrated comparability of Pavblu to the reference biologic drug Eylea. The results from a clinical comparative study demonstrated that no clinically meaningful differences in efficacy, safety, pharmacology, and immunogenicity were observed between Pavblu and Eylea in patients with wet AMD. Extrapolation to other sought indications (i.e., DME, BRVO, CRVO, or CNV) is based on scientific justifications, i.e. the same mechanism of action of aflibercept and the findings of consistent safety profiles across the indications currently approved for Eylea. The indications and recommended dose regimens for Pavblu are identical to the reference biologic drug Eylea.

A Risk Management Plan (RMP) for Pavblu was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Pavblu 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 materials were considered to be acceptable.

Based on the totality of evidence, including structural, functional, non-clinical, pharmacokinetic / pharmacodynamic (PK/PD) and clinical comparisons between the biosimilar Pavblu and the reference product Eylea, the benefit-risk profile of Pavblu is considered favourable for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

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