↓ Skip to main content

Biosimilars: a regulatory perspective from America

Overview of attention for article published in Arthritis Research & Therapy, January 2011
Altmetric Badge

Mentioned by

twitter
1 tweeter

Citations

dimensions_citation
44 Dimensions

Readers on

mendeley
81 Mendeley
You are seeing a free-to-access but limited selection of the activity Altmetric has collected about this research output. Click here to find out more.
Title
Biosimilars: a regulatory perspective from America
Published in
Arthritis Research & Therapy, January 2011
DOI 10.1186/ar3310
Pubmed ID
Authors

Jonathan Kay

Abstract

Biosimilars are protein products that are sufficiently similar to a biopharmaceutical already approved by a regulatory agency. Several biotechnology companies and generic drug manufacturers in Asia and Europe are developing biosimilars of tumor necrosis factor inhibitors and rituximab. A biosimilar etanercept is already being marketed in Colombia and China. In the US, several natural source products and recombinant proteins have been approved as generic drugs under Section 505(b)(2) of the Food, Drug, and Cosmetic Act. However, because the complexity of large biopharmaceuticals makes it difficult to demonstrate that a biosimilar is structurally identical to an already approved biopharmaceutical, this Act does not apply to biosimilars of large biopharmaceuticals. Section 7002 of the Patient Protection and Affordable Care Act of 2010, which is referred to as the Biologics Price Competition and Innovation Act of 2009, amends Section 351 of the Public Health Service Act to create an abbreviated pathway that permits a biosimilar to be evaluated by comparing it with only a single reference biological product. This paper reviews the processes for approval of biosimilars in the US and the European Union and highlights recent changes in federal regulations governing the approval of biosimilars in the US.

Twitter Demographics

The data shown below were collected from the profile of 1 tweeter who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 81 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 1 1%
Belgium 1 1%
Unknown 79 98%

Demographic breakdown

Readers by professional status Count As %
Researcher 22 27%
Student > Master 13 16%
Student > Bachelor 10 12%
Other 9 11%
Student > Doctoral Student 7 9%
Other 15 19%
Unknown 5 6%
Readers by discipline Count As %
Medicine and Dentistry 27 33%
Agricultural and Biological Sciences 16 20%
Biochemistry, Genetics and Molecular Biology 6 7%
Social Sciences 5 6%
Economics, Econometrics and Finance 4 5%
Other 16 20%
Unknown 7 9%

Attention Score in Context

This research output has an Altmetric Attention Score of 1. 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 23 August 2011.
All research outputs
#3,111,500
of 4,506,051 outputs
Outputs from Arthritis Research & Therapy
#796
of 1,080 outputs
Outputs of similar age
#38,738
of 61,465 outputs
Outputs of similar age from Arthritis Research & Therapy
#11
of 18 outputs
Altmetric has tracked 4,506,051 research outputs across all sources so far. This one is in the 22nd percentile – i.e., 22% of other outputs scored the same or lower than it.
So far Altmetric has tracked 1,080 research outputs from this source. They receive a mean Attention Score of 3.2. This one is in the 18th percentile – i.e., 18% of its peers scored the same or lower than it.
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 61,465 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 26th percentile – i.e., 26% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 18 others from the same source and published within six weeks on either side of this one. This one is in the 22nd percentile – i.e., 22% of its contemporaries scored the same or lower than it.