Evidence map›Paper›PMID 38507189›Full record

ArticleOphthalmology and therapy2024

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

Neungseon Seo, Xiaoyan Guan, Tian Wang, Hyo S Helen Chung, Mats Wikström, Rupa Padaki, Kevin Kalenian, Scott Kuhns, Kelli Matthies, Jill Crouse-Zeineddini and 5 more

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 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

15 authors.

Neungseon SeoAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA. neungseon.seo@amgen.com.ORCID http://orcid.org/0000-0001-7308-3191
Xiaoyan GuanAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Tian WangAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Hyo S Helen ChungAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Mats WikströmAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Rupa PadakiAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Kevin KalenianAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Scott KuhnsAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Kelli MatthiesAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Jill Crouse-ZeineddiniAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Helen Y WongAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Michael NgAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Ian N FoltzAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Shawn CaoAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.
Jennifer LiuAmgen Inc., One Amgen Center Drive, Thousand Oaks, CA, 91320-1799, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionABP 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).

methodsStructural 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.

resultsABP 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.

conclusionsABP 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.

Indexed as

ABP 938AfliberceptAnalytical similarityBiosimilar pharmaceuticalsEye diseasesStructural and functional similarityVEGF

Identifiers

PMID38507189
PMCPMC11039433

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Registered trials

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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.