Related Experiment Video
Updated: Mar 31, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Biosimilars in rheumatology: what the clinician should know
Gilberto Castañeda-Hernández1, Rodrigo González-Ramírez2, Jonathan Kay3
1Departamento de Farmacología , Centro de Investigación y de Estudios Avanzados del Instituto Politécnico Nacional , México, Distrito Federal , Mexico ; Centro Latino Americano de Pesquisa em Biológicos , Rio de Janeiro , Brazil.
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.
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Drugs for Treatment of Crohn's Disease in IBD Using Biologic Agents: Anti-TNF
Genome-wide Association Studies-GWAS
GWAS does not require the identification of the target gene involved in...
Bioequivalence: Overview
Bioequivalence of Drugs: Drugs with Multiple Indications
Bioequivalence studies: Biowaivers

