Regulation of biosimilar medicines and current perspectives on interchangeability and policy

• Published in: European journal of clinical pharmacology Vol. 75; no. 1; pp. 1 - 11
• Main Authors: O’Callaghan, J., Barry, S. P., Bermingham, M., Morris, J. M., Griffin, B. T.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01.01.2019; Springer Nature B.V
• Subjects: Animals; Australia; Biological products; Biological Products - administration & dosage; Biological Products - standards; Biomedical and Life Sciences; Biomedicine; Biosimilar Pharmaceuticals - administration & dosage; Biosimilar Pharmaceuticals - standards; Drug and Narcotic Control - legislation & jurisprudence; Drug Approval - legislation & jurisprudence; Europe; FDA approval; Humans; Pharmacology/Toxicology; Regulation; Review; United States; United States Food and Drug Administration; Australia; United States; Europe; United States > US; Policy; Regulation; Substitution; Interchangeability; Biosimilar; Switching

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be...