Department of Medicine, Division of Rheumatology
Complex Mixtures | Musculoskeletal Diseases | Pharmaceutics and Drug Design | Rheumatology
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.
Anti-TNF, Outcomes research, Pharmacokinetics
Rights and Permissions
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/
DOI of Published Version
RMD Open. 2015 May 23;1(1):e000010. doi: 10.1136/rmdopen-2014-000010. eCollection 2015. Link to article on publisher's site
Castaneda-Hernandez, Gilberto; Gonzalez-Ramirez, Rodrigo; Kay, Jonathan; and Scheinberg, Morton A., "Biosimilars in rheumatology: what the clinician should know" (2015). Open Access Articles. 2737.
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial 4.0 License