Biosimilars and patient safety risk: promoting policy protections in the health delivery system
DOI:
https://doi.org/10.7175/rhc.v3i2.203Keywords:
Biosimilars, Clinical risk, Patient safety, Health delivery systemReferences
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. blog.pharmexec.com, 2011. Available at: http://blog.pharmexec.com/2011/05/18/biosimilars-spend-to-reach-2-5-bln-by-2015-ims [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. SpecialtyPharmaJournal.com, 2011. Available at: http://www.specialtypharmajournal.com/index.php?option=com_content&view=article&id=2816:follow-on-biologics-a-biosimilars-literature-review-the-current-landscape-and-implications-of-recent-healthcare-legislation-for-the-us-market-&catid=425:catbiosimilars&Itemid=845 [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: http://www.help.senate.gov/old_site/Hearings/2007_03_08/Siegel.pdf [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]. europabio.org. Available at: http://www.europabio.org/sites/default/files/report/guide_to_biological_medicines_a_focus_on_biosimilar_medicines.pdf [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. ismp.org. Available at: http://www.ismp.org/Tools/highAlertMedications.asp [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
Published
Issue
Section
License
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal. The Publication Agreement can be downloaded here, and should be signed by the Authors and sent to the Publisher when the article has been accepted for publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
- Authors are permitted to post their work online after publication (the article must link to publisher version, in html format)
