Evidence map›Paper›PMID 38878130›Full record

ArticleOphthalmology and therapy2024

Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea

Hangyeore Lee, Jongcheol Huh, Dayoung Kim, Soye Lee, Jaeil Lee, Jungmin Lee, Beom Chan Kim, Jinsu Song

Abstract read
In one paragraph

Article in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Hangyeore Lee *Quality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Jongcheol Huh *Quality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Dayoung Kim *Quality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Soye Lee *Quality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Jaeil LeeQuality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Jungmin LeeQuality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Beom Chan KimQuality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea.
Jinsu SongQuality Evaluation Team, Samsung Bioepis Co. Ltd., Incheon, South Korea. jinsu.song@samsung.com.ORCID http://orcid.org/0000-0003-3733-2562

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSB15 is a proposed biosimilar product of reference aflibercept (Eylea

methodsA panel of state-of-the-art analytical methods was used for the comprehensive characterization of SB15 and US/EU-aflibercept. In terms of the structural and physicochemical properties, primary structure; post-translational modifications (PTM); higher-order structure; purity and impurities; charge variants; and glycosylation were compared. In addition, biological characterization including mechanism of action (MoA)-related and Fc-related biological activities was conducted.

resultsAnalytical similarity between SB15 and US/EU-aflibercept was demonstrated. The primary and higher-order structure of SB15 was confirmed to be comparable to that of US/EU-aflibercept. In addition, there were no meaningful differences in the physicochemical properties in terms of size and charge heterogeneity between SB15 and its RP. SB15 and RP were similar in biological activities including MoA-related binding activities, potencies, and Fc-related biological functions. Consequently, SB15 was confirmed to be highly similar to US/EU-aflibercept.

conclusionsBased on a comprehensive analytical similarity assessment of structural, physicochemical, and biological properties, SB15 was demonstrated to be highly similar to US/EU-aflibercept RP, supporting safe and effective use of SB15.

Indexed as

AfliberceptBiosimilarEylea®Samsung BioepisSB15

Identifiers

PMID38878130
PMCPMC11246345

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.