title: Biosimilars: where we were and where we are.
abstract: Recent progress in biosimilars development is overviewed, with attention to the history of issues and processes leading to current regulations, and to scientific considerations, including progress on design and operational implementation issues that arise and are peculiar to biosimilars trial design and implementation.
authors.affiliation: a Biosimilars Development-Scientific Affairs , PRA Health Sciences , Reading , Berkshire , United Kingdom.
authors.forename: Rodeina
authors.initials: R
authors.lastname: Challand
authors.forename: Hazel
authors.initials: H
authors.lastname: Gorham
authors.forename: John
authors.initials: J
authors.lastname: Constant
mesh_terms: D001702:Biopharmaceutics / Q000191:economics / Q000331:legislation & jurisprudence* / Q000639:trends*; D059451:Biosimilar Pharmaceuticals / Q000191:economics / Q000592:standards*; D017277:Drug Approval; D055808:Drug Discovery / Q000331:legislation & jurisprudence* / Q000592:standards / Q000706:statistics & numerical data / Q000639:trends*; D005062:European Union; D033161:Government Regulation; D014481:United States
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: Biosimilars; Regulatory framework; Statistical design