Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product

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2024年3月20日

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Neungseon Seo,
Xiaoyan Guan,
Tian Wang,
Hyo S. Helen Chung,
Mats Wikström,
Rupa Padaki,
Kevin Kalenian,
Scott Kuhns,
Kelli Matthies,
Jill Crouse-Zeineddini,
Helen Y. Wong,
Michael Ng,
Ian N. Foltz,
Shawn Cao,
Jennifer Liu

摘要

Introduction

ABP 938 is being developed as a biosimilar candidate to aflibercept reference product (RP), a biologic used for certain angiogenic eye disorders. This study was designed to provide a comparative analytical assessment of the structural and functional attributes of ABP 938 and aflibercept RP sourced from the United States (US) and the European Union (EU).

Methods

Structural and functional characterization studies were performed using state-of-the-art analytical techniques that were appropriate to assess relevant quality attributes and capable of detecting qualitative and quantitative differences in primary structure, higher-order structure and biophysical properties, product-related substances and impurities, general properties, and biological activities.

Results

ABP 938 had the same amino acid sequence and exhibited similar secondary and tertiary structures, and biological activity as aflibercept RP. There were minor differences in a small number of biochemical attributes which are not expected to impact clinical performance. In addition, aflibercept RP sourced from the US and EU were analytically similar.

Conclusions

ABP 938 was structurally and functionally similar to aflibercept RP. Since aflibercept RP sourced from the US and EU were analytically similar, this allows for the development of a scientific bridge such that a single-source RP can be used in nonclinical and clinical studies.