Patient attitudes and understanding about biosimilars: An international cross-sectional survey

Patient Preference and Adherence

Volumn 10, Issue , 2016, Pages 937-948

  Jacobs, Ira ^a   Singh, Ena ^a   Sewell, K Lea ^a   Al Sabbagh, Ahmad ^a   Shane, Lesley G ^a  

^a PFIZER INC   (United States)

Author keywords

Advocacy groups; Biologic therapy; Biosimilar; Cancer; Inflammatory disease; Oncology; Patient education; Treatment

Indexed keywords

BIOLOGICAL PRODUCT; BIOSIMILAR; UNCLASSIFIED DRUG;

ADULT; AGED; ARTICLE; AWARENESS; BREAST CANCER; CAREGIVER; COLORECTAL CANCER; CROHN DISEASE; DRUG EFFICACY; DRUG SAFETY; DRUG USE; EUROPEAN UNION; FEMALE; HEALTH SURVEY; HUMAN; KNOWLEDGE; LUNG CANCER; MAJOR CLINICAL STUDY; MALE; NONHODGKIN LYMPHOMA; PATIENT ATTITUDE; PERCEPTION; PSORIASIS; RHEUMATOID ARTHRITIS; ULCERATIVE COLITIS; UNITED STATES;

EID: 84969750878     PISSN: None     EISSN: 1177889X     Source Type: Journal    
DOI: 10.2147/PPA.S104891     Document Type: Article

References (21)

1. US Food and Drug Administration [homepage on the Internet]. FDA approves first biosimilar product Zarxio [FDA news release]. US Food and Drug Administration; 2016 [updated March 6, 2016]. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm. Accessed March 23, 2016.
2. European Medicines Agency [homepage on the Internet]. Guideline on similar biological medicinal products containing monoclonal antibodies-non-clinical and clinical issues [report]. London: European Medicines Agency Committee for Medicinal Products for Human Use (CHMP); 2010 [updated May 30, 2012]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf. Accessed August 25, 2015.
3. Health Canada [homepage on the Internet]. Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) [report]. Ottawa, ON, Canada: Health Products and Food Branch, Health Canada; 2010 [updated March 5, 2010]. Available from: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/brgtherap/applic-demande/guides/seb-pbu/seb-pbu-2010-eng.pdf. Accessed August 25, 2015.
4. World Health Organization [homepage on the Internet]. Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs) [report]. Geneva, Switzerland: World Health Organization Expert Committee on Biological Standardization; 2009 [updated October 19, 2009]. Available from: http://www.who.int/biologicals/areas/biological_therapeutics/BIOTHERAPEUTICS_FOR_WEB_22APRIL2010.pdf. Accessed April 7, 2015.
5. US Food and Drug Administration [homepage on the Internet]. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Guidance for Industry [report]. Silver Spring, MD: US Department of Health and Human Services, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER); 2015 [updated April 2015]. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Accessed April 7, 2015.
6. European Medicines Agency [homepage on the Internet]. Guideline on Similar Biological Medicinal Products [report]. London: European Medicines Agency Committee for Medicinal Products for Human Use (CHMP); 2014 [updated October 23, 2014]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed June 5, 2015.
7. European Medicines Agency [homepage on the Internet]. Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues. Draft [report]. London: European Medicines Agency Committee for Medicinal Products for Human Use (CHMP); c2013 [updated June 3, 2013]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/06/WC500144124.pdf. Accessed August 25, 2015.
8. Vital EM, Kay J, Emery P. Rituximab biosimilars. Expert Opin Biol Ther. 2013;13(7):1049-1062.
9. IBM Corporation [homepage on the Internet]. Column Proportions Test [user guide]. Armonk, NY: IBM Corporation; 2013 [updated 2013]. Available from: http://www-01.ibm.com/support/knowledgecenter/SSLVQG_7.0.0/com.spss.reportsforsurveys/column_proportions_test.htm?lang=en. Accessed May 13, 2015.
10. Nijsten T, Bergstresser PR. Patient advocacy groups: let’s stick together. J Invest Dermatol. 2010;130(7):1757-1759.
11. Generics and Biosimilars Initiative (GaBi) Online [homepage on the Internet]. Biosimilars approved in Europe [global news report]. Mol, Belgium: Pro Pharma Communications International; 2011 [updated February 27, 2015]. Available from: http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe. Accessed April 21, 2015.
12. European Biopharmaceutical Enterprises. Tell me the whole story: the role of product labelling in building user confidence in biosimilars in Europe. GaBi J. 2014;3(4):1-6.
13. American Autoimmune Related Diseases Association [homepage on the Internet]. Leading Autoimmune Patient Advocacy Group Survey Finds Overwhelming Majority of Patients Lack Understanding of Biosimilar Drugs [media release]. New York, NY: Carway Communications, Inc; 2015 [updated February 11, 2015]. Available from: http://www.aarda.org/wp-content/uploads/2015/02/BiosimilarsWhitePaperPressRelease.pdf. Accessed March 10, 2015.
14. Colbert RA, Cronstein BN. Biosimilars: the debate continues. Arthritis Rheum. 2011;63(10):2848-2850.
15. Kozlowski S, Woodcock J, Midthun K, Sherman RB. Developing the nation’s biosimilars program. N Engl J Med. 2011;365(5):385-388.
16. Sarpatwari A, Avorn J, Kesselheim AS. Progress and hurdles for follow-on biologics. N Engl J Med. 2015;372(25):2380-2382.
17. Patient advocates: expanding their role in conducting successful clinical trials. J Oncol Pract. 2006;2(6):298-299.
18. Madsen SM, Holm S, Davidsen B, Munkholm P, Schlichting P, Riis P. Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Intern Med. 2000;248(6):463-474.
19. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P. Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med. 2002;251(2):156-168.
20. Rompas S, Goss T, Amanuel S, et al. Demonstrating value for biosimilars: a conceptual framework. Am Health Drug Benefits. 2015;8(3):129-139.
21. Socinski MA, Curigliano G, Jacobs I, Gumbiner B, MacDonald J, Thomas D. Clinical considerations for the development of biosimilars in oncology. MAbs. 2015;7(2):286-293.