Development of Biosimilar Aflibercept SDZ-AFL

Area of Science:

• Ophthalmology
• Pharmacology
• Biotechnology

Background:

• Aflibercept (Ref-AFL) is a key biologic therapy for retinal diseases like neovascular age-related macular degeneration (nAMD).
• High costs of biologic agents can limit patient access to essential treatments.
• Biosimilar development aims to provide more affordable alternatives with comparable therapeutic profiles.

Purpose of the Study:

• To evaluate the biosimilarity of Sandoz biosimilar aflibercept (SDZ-AFL) to reference aflibercept (Ref-AFL).
• To summarize the comprehensive data package supporting the approval of SDZ-AFL as a biosimilar.

Main Methods:

• Physicochemical and biological characterization of SDZ-AFL and Ref-AFL.
• In vitro studies assessing structural homology and biological activity.
• Ocular pharmacokinetic studies in rabbits and Phase III clinical trials in nAMD patients.

Main Results:

• SDZ-AFL demonstrated structural homology and highly similar in vitro biological activities compared to Ref-AFL.
• Ocular and systemic pharmacokinetic profiles were comparable between SDZ-AFL and Ref-AFL.
• Phase III trials showed comparable efficacy, safety, and immunogenicity, meeting bioequivalence criteria for visual acuity.

Conclusions:

• The totality of evidence confirms biosimilarity between SDZ-AFL and Ref-AFL.
• SDZ-AFL is expected to enhance patient access to aflibercept therapy for retinal diseases.
• The availability of aflibercept biosimilars may reduce treatment barriers and expand patient benefit.