UMMS Affiliation

Department of Medicine, Division of Rheumatology

Publication Date

5-23-2015

Document Type

Article

Disciplines

Complex Mixtures | Musculoskeletal Diseases | Pharmaceutics and Drug Design | Rheumatology

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

Journal/Book/Conference Title

RMD open

PubMed ID

26509046

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License

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