Biosimilars and patient safety risk: promoting policy protections in the health delivery system

Bryan A. Liang, Timothy Mackey



Biosimilars; Clinical risk; Patient safety; Health delivery system

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  • Liang B. Regulating Follow-On Biologics. Harv J Legis 2007; 44: 363-471
  • Silverman E. Drug pipeline loses pressure. Manag Care 2010; 19: 23-6
  • Comer B. Biosimilars Spend to Reach $2.5 Bln by 2015., 2011. Available at: [last accessed Mar. 27, 2012]
  • Maiese BA, Lee EH, Toscani M. Follow-on biologics & biosimilars literature review: the current landscape and implications of recent healthcare legislation for the U.S. market., 2011. Available at: [last accessed Mar. 8, 2012]
  • Roger SD. Biosimilars: How similar or dissimilar are they? Nephrology 2006; 11: 341-6
  • Statement of Jay P. Siegel, M.D., Johnson & Johnson. Before the Senate Committee on Health,
  • Education, Labor, and Pensions: Follow-on Biologics, 2007 Available at: [last accessed Mar. 12, 2012]
  • Leuenberger-Fisher MR. The road to follow on biologics: are we there yet? Biotech Law Rep 2004; 23: 389-401
  • EuropaBio. Guide to biological medicines: a focus on biosimilar medicines [Internet]. Available at: [last accessed Mar. 12, 2012]
  • Chamberlain P. Immunogenicity of therapeutic proteins. Part 1: Causes and clinical manifestations of immunogenicity. Reg Rev 2002; 5: 5-9
  • Bennett CL, Cournoyer D, Carson KR, et al. Long-term outcome of individuals with pure red cell aplasia and antierythropoietin antibodies in patients treated with recombinant epoetin: a follow-up report from the Research on Adverse Drug Events and Reports (RADAR) Project. Blood 2005; 106: 3343-7
  • Schellekens H, Jiskoot W. Eprex-associated pure red cell aplasia and leachates. Nat Biotechnol 2006; 24: 613-4
  • ISMP. ISMP’s High-Alert Medications List. Available at: [last accessed Mar. 22, 2012]
  • Mackey TK, Liang BA. The global counterfeit drug trade: Patient safety and public health risks. J Pharm Sci 2011; 100: 4571-9
  • Liang BA, Mackey T. Reforming direct-to-consumer advertising. Nat Biotechnol 2011; 29: 397-400
  • Liang BA, Mackey T. Emerging patient safety issues under health care reform: follow-on biologics and immunogenicity. Ther Clin Risk Manag 2011; 7: 489-93


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