Analytical and Functional Similarity of Aflibercept Biosimilar ABP 938 with Aflibercept Reference Product
© 2024. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:13 |
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| Enthalten in: |
Ophthalmology and therapy - 13(2024), 5 vom: 20. Apr., Seite 1303-1320 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Seo, Neungseon [VerfasserIn] |
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| Links: |
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| Themen: |
ABP 938 |
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| Anmerkungen: |
Date Revised 26.04.2024 published: Print-Electronic Citation Status PubMed-not-MEDLINE |
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| doi: |
10.1007/s40123-024-00914-1 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM369967917 |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a ABP 938 | |
| 650 | 4 | |a Aflibercept | |
| 650 | 4 | |a Analytical similarity | |
| 650 | 4 | |a Biosimilar pharmaceuticals | |
| 650 | 4 | |a Eye diseases | |
| 650 | 4 | |a Structural and functional similarity | |
| 650 | 4 | |a VEGF | |
| 700 | 1 | |a Guan, Xiaoyan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Tian |e verfasserin |4 aut | |
| 700 | 1 | |a Chung, Hyo S Helen |e verfasserin |4 aut | |
| 700 | 1 | |a Wikström, Mats |e verfasserin |4 aut | |
| 700 | 1 | |a Padaki, Rupa |e verfasserin |4 aut | |
| 700 | 1 | |a Kalenian, Kevin |e verfasserin |4 aut | |
| 700 | 1 | |a Kuhns, Scott |e verfasserin |4 aut | |
| 700 | 1 | |a Matthies, Kelli |e verfasserin |4 aut | |
| 700 | 1 | |a Crouse-Zeineddini, Jill |e verfasserin |4 aut | |
| 700 | 1 | |a Wong, Helen Y |e verfasserin |4 aut | |
| 700 | 1 | |a Ng, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Foltz, Ian N |e verfasserin |4 aut | |
| 700 | 1 | |a Cao, Shawn |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Jennifer |e verfasserin |4 aut | |
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