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Analysis of Global Medical Literature Shows Exponential Increase in Biosimilar Research


The researchers found that the majority of publications on biosimilars came from high-income countries, led by the United States.

The quality and quantity of worldwide research on biosimilars is increasing, reflecting an increasing interest in the use of biosimilar treatments in a number of diseases, according to the first published bibliometric analysis of biosimilars, by Akram Hernández-Vásquez, MD, MSc, and colleagues in the Journal of Pharmaceutical Policy and Practice. The researchers found that the majority of publications on biosimilars came from high-income countries, led by the United States (29.4%), followed by Germany (12.5%) and the United Kingdom (10.6%), following the distribution of countries that have policies to promote biosimilar drug approvals, the authors note.

Bibliometric analysis is used to objectively measure current research into a subject and its international scientific influence, which is used as a factor judging scientific quality. The researchers searched for reviews, articles, editorials, and letters using the terms “biosimilar pharmaceutical” or “biosimilar” that were published between 2004 and December 2016 in journals indexed in Scopus, the largest abstract and citation database of scientific peer-reviewed literature that includes all MEDLINE documents and further characteristics such as country of authors and citations per document. Data were quantitatively and qualitatively analyzed using Microsoft Excel 2013 and Bibliometrix analysis software.

A total of 2330 biosimilar-related documents were identified in the Scopus database between 2004 and 2016. The researchers found that the number of documents published on biosimilars increased exponentially between 2004 and 2016, going from 3 in 2004 to 521 in 2016 (P <.001). Amgen was listed the most prolific institution associated with the biosimilar publications (51 documents), followed by Pfizer (48 documents). However, the study's authors did not list Novartis and Sandoz as a single company; consideration of the 33 publications ascribed to Sandoz and the 19 ascribed to Novartis together would result in Novartis—Sandoz being the most prolific institution in this area.

The top 5 most-cited papers were original articles; the top 2 were guidelines for management of rheumatoid arthritis (RA) and febrile neutropenia. The researchers note that their finding makes sense because there are already several biosimilars available to treat RA and febrile neutropenia.

Terminology associated with the publications on biosimilars also changed over the years. Terms such as “legislation,” “structure,” “protein,” “dose,” and “generic” dominated in the earlier range of years examined, whereas more recently, specific diseases and drugs were the top terms used, mirroring the overall trends associated with biosimilar development.


Hernández-Vásquez A, Alarcon-Ruiz CA, Bendezu-Quispe G, Comande D, Rosselli D. A bibliometric analysis of the global research on biosimilars. [Published online March 27, 2018.] J Pharm Policy Pract. doi:10.1186/s40545-018-0133-2.

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