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Biosimilars in rheumatology: what the clinician should know
Open Access Articles
  • Gilberto Castaneda-Hernandez, National Polytechnic Institute
  • Rodrigo Gonzalez-Ramirez, National Polytechnic Institute
  • Jonathan Kay, University of Massachusetts Medical School
  • Morton A. Scheinberg, Hospital Israelita Albert Einstein
UMMS Affiliation
Department of Medicine, Division of Rheumatology
Date
5-23-2015
Document Type
Article
Abstract
Biosimilars are now a reality in rheumatology. Although analytical and non-clinical procedures to establish similarity have evolved significantly, clinical trials demonstrating equivalent efficacy and safety are absolutely required for all biosimilars. The design of such trials, including equivalence and non-inferiority statistical approaches, are discussed. Clinical evidence on biosimilars that have been approved recently or are presently being developed for use in rheumatology is also reviewed and contrasted with that available for biomimics (or intended copies), which are non-innovator biologics that are marketed in several countries but have not undergone review according to a regulatory pathway for biosimilars.
Rights and Permissions
Citation: RMD Open. 2015 May 23;1(1):e000010. doi: 10.1136/rmdopen-2014-000010. eCollection 2015. Link to article on publisher's site
DOI of Published Version
10.1136/rmdopen-2014-000010
Comments

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

Related Resources
Link to Article in PubMed
Keywords
  • Anti-TNF,
  • Outcomes research,
  • Pharmacokinetics
PubMed ID
26509046
Creative Commons License
Creative Commons Attribution-Noncommercial 4.0
Citation Information
Gilberto Castaneda-Hernandez, Rodrigo Gonzalez-Ramirez, Jonathan Kay and Morton A. Scheinberg. "Biosimilars in rheumatology: what the clinician should know" Vol. 1 Iss. 1 (2015) ISSN: 2056-5933 (Linking)
Available at: http://works.bepress.com/jonathan_kay/18/