Assessment of pharmacists' views on biosimilar naming conventions

Journal of Managed Care Pharmacy

Volumn 21, Issue 3, 2015, Pages 188-195

  Fernandez Lopez, Sara ^a   Kazzaz, Denise ^a   Bashir, Mohamed ^b   McLaughlin, Trent ^a  

^a XCENDA   (United States)

^b Next Generation Marketing Insights   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; FILGRASTIM; HUMAN GROWTH HORMONE; INFLIXIMAB; INSULIN GLARGINE; RECOMBINANT ERYTHROPOIETIN; RECOMBINANT FOLLITROPIN;

ARTICLE; COMPUTER PROGRAM; ELECTRONIC MEDICAL RECORD; ELECTRONIC PRESCRIBING; HEALTHCARE COMMON PROCEDURE CODING SYSTEM; HOSPITAL; HUMAN; MANAGED CARE ORGANIZATION; MEDICAL INFORMATICS; MEDICAL SOCIETY; PHARMACIST; PHARMACIST ATTITUDE; UNITED STATES; DRUG APPROVAL; HEALTH PERSONNEL ATTITUDE; INFORMATION PROCESSING; NOMENCLATURE; STATISTICS AND NUMERICAL DATA;

ATTITUDE OF HEALTH PERSONNEL; BIOSIMILAR PHARMACEUTICALS; DATA COLLECTION; DRUG APPROVAL; HUMANS; PHARMACISTS; TERMINOLOGY AS TOPIC; UNITED STATES;

EID: 84930157900     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2015.21.3.188     Document Type: Article

References (18)

1. Patient Protection and Affordable Care Act. Public Law 111-148: 124 Statute 119. 111th Congress. March 23, 2010. Available at: http://beta.congress. gov/111/plaws/publ148/PLAW-111publ148.pdf. Accessed February 5, 2015.
2. Novartis Global. Media releases. FDA accepts Sandoz application for biosimilar filgrastim. July 24, 2014. Available at: http://www.novartis.com/newsroom/media-releases/en/2014/1835571.shtml. Accessed February 5, 2015.
3. Novartis Global. Media releases. Sandoz biosimilar filgrastim recommended for approval by FDA Oncologic Drugs Advisory Committee. January 7, 2015. Available at: http://www.novartis.com/newsroom/media-releases/en/2015/1885139.shtml. Accessed February 5, 2015.
4. Celltrion. What's New? Celltrion files for U.S. FDA approval of Remsima. August 11, 2014. Available at: http://www.celltrion.com/en/COMPANY/notice:view.asp?idx=456&code=ennews&intNowPage=1&menu_ num=&align_year=all. Accessed February 5, 2015.
5. Apotex. Apotex announces FDA has accepted for filing its biosimilar application for pegfilgrastim. December 17, 2014. Available at: http://www. apotex.com/global/about/press/20141217.asp. February 5, 2015.
6. Hospira. Press release. Hospira submits new biologics license application to U.S. FDA for proposed epoetin alfa biosimilar. January 12, 2015. Available at: http://phx.corporate-ir.net/phoenix.zhtml?c=175550&p=irolnewsArticle& ID=2006860. Accessed February 5, 2015.
7. U.S. Food and Drug Administration. Biosimilars guidances. [A complete listing of the biosimilars guidances published between March 2013 and August 2014]. Available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm290967.htm. Accessed February 5, 2015.
8. U.S. Food and Drug Administration. Generic Pharmaceutical Association-citizen petition. September 17, 2013. Available at: http://www. regulations.gov/#!documentDetail;D=FDA-2013-P-1153-0001. Accessed February 5, 2015.
9. Letter to Commissioner Magaret A. Hamburg from multiple stakeholder organizations re consumers to the FDA on biosimilars INN. July 1, 2014. Available at: http://www.gphaonline.org/media/cms/Lttr_to_FDA_on_biosimilars_ INN_June_2014.FINAL.pdf. Accessed February 5, 2015.
10. Dolinar R. Letter to Commissioner Margaret A. Hamburg re the Alliance for Safe Biologic Medicines to the Food and Drug Administration on naming of biologics. August 30, 2012. Available at: http://safebiologics.org/pdf/asbmnaming. pdf. Accessed February 5, 2015.
11. Saltonstall PL. Letter to Commissioner Margaret A. Hamburg re National Organization for Rare Disorder (NORD) and adoption of distinguishable names for biologics. June 3, 2014. Available at: http://rarediseases.org/advocacy/policy-statements/NORDSupportsSeparateNamingforBiosimilars.pdf. Accessed February 5, 2015.
12. American Medical Association. How to apply for a name. Available at:http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-states-adopted-names-council/how-to-apply-for-usan.page. Accessed February 5, 2015.
13. American Medical Association. United States adopted names: latest news. Available at: http://www.ama-assn.org/ama/pub/physician-resources/medical-science/united-states-adopted-names-council.page. Accessed February 5, 2015.
14. U.S. Food and Drug Administration. Guidance for industry: contents of a complete submission for the evaluation of proprietary names. February 2010. Available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm075068.pdf. Accessed February 5, 2015.
15. World Health Organization. Biological qualifier: an INN proposal. INN Working Doc. 14.342. Revised draft July 2014. Available at: http://www.who. int/medicines/services/inn/bq_innproposal201407.pdf. Accessed February 5, 2015.
16. Wolgemuth L, Jeffries JA. Alexander, Hatch call on Burwell to immediately release guidance on biosimilar drugs. U.S. Senate Committee on Health, Education, Labor and Pensions. August 1, 2014. Available at: http://www.help.senate.gov/newsroom/press/release/?id=d3a2624c-2410-4d08-b76e-883592c3885a. Accessed on February 5, 2015.
17. AMCP Task Force on Biosimilar Collective Intelligence Systems. Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products. J Manag Care Spec Pharm. 2015;21(1):23-34. Available at:http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=18903.
18. European Medicine Agency. European public assessment reports. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedi cines%2Flanding%2Fepar_search.jsp&mid=WC0b01ac058001d124&searc hTab=searchByAuthType&alreadyLoaded=true&isNewQuery=true&status= Authorised&status=Withdrawn&status=Suspended&status=Refused&keyw ord=Enter+keywords&searchType=name&taxonomyPath=&treeNumber=& searchGenericType=biosimilars&genericsKeywordSearch=Submit. Accessed February 5, 2015.