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Biosimilars and the extrapolation of indications for inflammatory conditions

Overview of attention for article published in Biologics: Targets & Therapy, February 2017
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About this Attention Score

  • In the top 25% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#22 of 283)
  • High Attention Score compared to outputs of the same age (90th percentile)

Mentioned by

news
1 news outlet
twitter
8 X users
facebook
1 Facebook page
googleplus
1 Google+ user

Citations

dimensions_citation
54 Dimensions

Readers on

mendeley
71 Mendeley
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Title
Biosimilars and the extrapolation of indications for inflammatory conditions
Published in
Biologics: Targets & Therapy, February 2017
DOI 10.2147/btt.s124476
Pubmed ID
Authors

John RP Tesser, Daniel E Furst, Ira Jacobs

Abstract

Extrapolation is the approval of a biosimilar for use in an indication held by the originator biologic not directly studied in a comparative clinical trial with the biosimilar. Extrapolation is a scientific rationale that bridges all the data collected (ie, totality of the evidence) from one indication for the biosimilar product to all the indications originally approved for the originator. Regulatory approval and marketing authorization of biosimilars in inflammatory indications are made on a case-by-case and agency-by-agency basis after evaluating the totality of evidence from the entire development program. This totality of the evidence comprises extensive comparative analytical, functional, nonclinical, and clinical pharmacokinetic/pharmacodynamic, efficacy, safety, and immunogenicity studies used by regulators when evaluating whether a product can be considered a biosimilar. Extrapolation reduces or eliminates the need for duplicative clinical studies of the biosimilar but must be justified scientifically with appropriate data. Understanding the concept, application, and regulatory decisions based on the extrapolation of data is important since biosimilars have the potential to significantly impact patient care in inflammatory diseases.

X Demographics

X Demographics

The data shown below were collected from the profiles of 8 X users who shared this research output. Click here to find out more about how the information was compiled.
Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 71 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Belgium 1 1%
Unknown 70 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 16 23%
Other 9 13%
Researcher 7 10%
Student > Ph. D. Student 5 7%
Professor > Associate Professor 4 6%
Other 11 15%
Unknown 19 27%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 17 24%
Medicine and Dentistry 17 24%
Biochemistry, Genetics and Molecular Biology 5 7%
Mathematics 1 1%
Business, Management and Accounting 1 1%
Other 5 7%
Unknown 25 35%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 15. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 27 June 2023.
All research outputs
#2,401,330
of 25,390,692 outputs
Outputs from Biologics: Targets & Therapy
#22
of 283 outputs
Outputs of similar age
#46,722
of 416,345 outputs
Outputs of similar age from Biologics: Targets & Therapy
#1
of 3 outputs
Altmetric has tracked 25,390,692 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 90th percentile: it's in the top 10% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 283 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.2. This one has done particularly well, scoring higher than 92% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 416,345 tracked outputs that were published within six weeks on either side of this one in any source. This one has done particularly well, scoring higher than 90% of its contemporaries.
We're also able to compare this research output to 3 others from the same source and published within six weeks on either side of this one. This one has scored higher than all of them