title: Biosimilars in rheumatology: understanding the rigor of their development.
abstract: This article examines the current landscape of biosimilar development in rheumatology. As misperceptions about biosimilars exist regarding their comparability to the reference products for clinical use, we review the development paradigm with the goal of improving rheumatologists' understanding of the rigor with which biosimilars are developed. With an emphasis on European Union and US markets, it gives an overview of some of the challenges and issues related to biosimilar development that need to be considered by rheumatologists in this increasingly growing therapeutic space.
authors.affiliation: Advisory Services, Quintiles niti.goel@quintiles.com.|Department of Internal Medicine, Duke University School of Medicine.
authors.forename: Niti
authors.initials: N
authors.lastname: Goel
authors.affiliation: Biosimilars Center of Excellence, Quintiles, Durham, NC, USA.
authors.forename: Kamali
authors.initials: K
authors.lastname: Chance
mesh_terms: D018501:Antirheumatic Agents / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000627:therapeutic use*; D055808:Drug Discovery; D005062:European Union; D006801:Humans; D012216:Rheumatic Diseases / Q000188:drug therapy*; D012219:Rheumatology; D014481:United States
chemical_list: D018501:Antirheumatic Agents; D059451:Biosimilar Pharmaceuticals
keywords: adalimumab; biologics; biosimilar; development; etanercept; infliximab; psoriasis; rheumatoid arthritis; rheumatology