Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: Results of a French web-based survey

mAbs

Volumn 9, Issue 2, 2017, Pages 383-390

  Beck, Morgane ^a   Michel, Bruno ^a,b,c   Rybarczyk Vigouret, Marie Christine ^a   Levêque, Dominique ^b   Sordet, Christelle ^b   Sibilia, Jean ^b   Velten, Michel ^d  

^a Des Dispositifs Medicaux et de L'innovation Therapeutique Alsace   (France)

^b UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^c Université de Strasbourg   (France)

^d UNIVERSITÉ DE STRASBOURG   (France)

Author keywords

Biosimilar medicine; community pharmacist; experience; hospital pharmacist; knowledge; opinion; survey

Indexed keywords

BIOSIMILAR AGENT;

DRUG LEGISLATION; DRUG SAFETY; FRANCE; HEALTH CARE COST; HEALTH CARE SURVEY; HUMAN; PHARMACIST; PHARMACIST ATTITUDE; PRESCRIPTION; PROFESSIONAL KNOWLEDGE; PROFESSIONAL PRACTICE; ADULT; AGED; ATTITUDE TO HEALTH; FEMALE; INTERNET; MALE; MIDDLE AGED; QUESTIONNAIRE; YOUNG ADULT;

ADULT; AGED; BIOSIMILAR PHARMACEUTICALS; FEMALE; FRANCE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HUMANS; INTERNET; MALE; MIDDLE AGED; PHARMACISTS; SURVEYS AND QUESTIONNAIRES; YOUNG ADULT;

EID: 85009260842     PISSN: 19420862     EISSN: 19420870     Source Type: Journal    
DOI: 10.1080/19420862.2016.1267087     Document Type: Article

References (48)

1. Stats ATIH, [Internet]. [cited 2016Mar30]. Available from:http://www.scansante.fr/
2. Bocquet F. Les Médicaments Biosimilaires:enjeux économiques et politiques. Paris:Éditions de santé; 2015.
3. Gulácsi L, Brodszky V, Baji P, Kim H, Kim SY, Cho YY, Péntek M. Biosimilars for the management of rheumatoid arthritis:economic considerations. Expert Rev Clin Immunol 2015; 11 Suppl 1:43-52; PMID:26395836; http://dx.doi.org/10.1586/1744666X.2015.1090313
4. Isaacs JD, Cutolo M, Keystone EC, Park W, Braun J. Biosimilars in immune-mediated inflammatory diseases:initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody. J Intern Med 2016; 279(1):41-59; PMID:26403380; http://dx.doi.org/10.1111/joim.12432
5. Haustein R, de Millas C, Höer A, Häussler H. Saving money in the European healthcare systems with biosimilars. Generics Biosimilars Initiat J 2012; 1(3–4):120-6; http://dx.doi.org/10.5639/gabij.2012.0103-4.036
6. Brodszky V, Baji P, Balogh O, Péntek M. Budget impact analysis of biosimilar infliximab (CT-P13) for the treatment of rheumatoid arthritis in six Central and Eastern European countries. Eur J Health Econ HEPAC Health Econ Prev Care 2014; 15 Suppl 1:S65-71; PMID:24832837; http://dx.doi.org/10.1007/s10198-014-0595-3
7. Jha A, Upton A, Dunlop WC, Akehurst R. The Budget Impact of Biosimilar Infliximab (Remsima(®)) for the Treatment of Autoimmune Diseases in Five European Countries. Adv Ther 2015; 32(8):742-56; PMID:26343027; http://dx.doi.org/10.1007/s12325-015-0233-1
8. Beck M, Michel B, Rybarczyk-Vigouret MC, Sordet C, Sibilia J, Velten M. Biosimilar infliximab for the management of rheumatoid arthritis in France:what are the expected savings? Eur J Hosp Pharm. http://dx.doi.org/10.1136/ejhpharm-2016-000904
9. Farfan-Portet MI, Gerkens S, Lepage-Nefkens I, Vinck I, Hulstaert F. Are biosimilars the next tool to guarantee cost-containment for pharmaceutical expenditures? Eur J Health Econ 2014; 15:223-8; PMID:24271016; http://dx.doi.org/10.1007/s10198-013-0538-4
10. DeVries JH, Gough SC, Kiljanski J, Heinemann L. Biosimilar insulins:a European perspective. Diabetes Obes Metab 2015; 17(5):445-51; PMID:25376600; http://dx.doi.org/10.1111/dom.12410
11. Declerck PJ, Simoens S. A European perspective on the market accessibility of biosimilars. Biosimilars 2012; 2:33-40; http://dx.doi.org/10.2147/BS.S33524
12. Dylst P, Vulto A, Simoens S. Barriers to the uptake of biosimilars and possible solutions:a Belgian case study. Pharmacoeconomics 2014; 32(7):681-91; PMID:24803078; http://dx.doi.org/10.1007/s40273-014-0163-9
13. Bocquet F, Paubel P, Fusier F, Cordonnier AL, Sinègre M, Le Pen C. Biosimilar versus patented erythropoietins:learning from 5 years of European and Japanese experience. Appl Health Econ Health Policy 2015; 13(1):47-59; PMID:25189295; http://dx.doi.org/10.1007/s40258-014-0125-6
14. Bocquet F, Loubière A, Fusier I, Cordonnier AL, Paubel P. Competition between biosimilars and patented biologics:learning from European and Japanese experience. Pharmacoeconomics 2016; 34(11):1173-86; PMID:27412251; http://dx.doi.org/10.1007/s40273-016-0428-6
15. Bocquet F, Paubel P, Fusier I, Cordonnier AL, Le Pen C, Sinègre M. Biosimilar granulocyte colony-stimulating factor uptakes in the EU-5 markets:a descriptive analysis. Appl Health Econ Health Policy 2014; 12(3):315-26; PMID:24578185; http://dx.doi.org/10.1007/s40258-014-0087-8
16. Mestre-Ferrandiz J, Towse A, Berdud M. Biosimilars:how can payers get long-term savings? Pharmacoeconomics 2016; 34(6):609-16; PMID:26792791; http://dx.doi.org/10.1007/s40273-015-0380-x
17. Girault D, Trouvin JH, Blachier-Poisson C, Gary F, Laloye D, participants of round table N°3 of Giens XXX, Bergmann JF, Casadevall N, Delval C, De Sahb Berkovitch R, et al. Biosimilars:from Technical to Pharmacoeconomic Considerations. Therapie 2015; 70(1):47-55; PMID:27393396; http://dx.doi.org/10.2515/therapie/2015003
18. Lucio SD, Stevenson JG, Hoffman JM. Biosimilars:Implications for health-system pharmacists. Am J Health-Syst Pharm AJHP Off J Am Soc Health-Syst Pharm 2013; 70(22):2004-17; PMID:24173009; http://dx.doi.org/10.2146/ajhp130119
19. European Medicines Agency (EMA). Guideline on similar biological medicinal products. [Internet]. 2014 [cited 2015Apr21]. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf
20. European Medicines Agency (EMA). Guideline on similar biological medicinal products containing monoclonal antibodies - non-clinical and clinical issues. [Internet]. 2012 [cited 2015Oct29]. Available from:http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128686.pdf
21. Kurki P, Ekman N. Biosimilar regulation in the EU. Expert Rev Clin Pharmacol. 2015; 8(5):649-59; PMID:26294076; http://dx.doi.org/10.1586/17512433.2015.1071188
22. Calvo B, Zuñiga L. The US approach to biosimilars:the long-awaited FDA approval pathway. BioDrugs Clin Immunother Biopharm Gene Ther 2012; 26(6):357-61; PMID:23030677; http://dx.doi.org/10.2165/11635830-000000000-00000
23. Weise M, Bielsky M-C, De Smet K, Ehmann F, Ekman N, Giezen TJ, Gravanis I, Heim HK, Heinonen E, Ho K, et al. Biosimilars:what clinicians should know. Blood 2012; 120(26):5111-7; PMID:23093622; http://dx.doi.org/10.1182/blood-2012-04-425744
24. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars:the science of extrapolation. Blood 2014; 124(22):3191-6; PMID:25298038; http://dx.doi.org/10.1182/blood-2014-06-583617
25. Bocquet F, Paubel P. First monoclonal antibody biosimilars:tackling the challenge of substitution. J Med Econ 2016; 19(6):645-7; PMID:27080815; http://dx.doi.org/10.1080/13696998.2016.1178649
26. Mendoza C, Ionescu D, Radière G, Rémuzat C, Young KE, Toumi M. Biosimilar Substitution Policies:An Overview. Value Health J Int Soc Pharmacoeconomics Outcomes Res 2015; 18(7):A525; PMID:26532944; http://dx.doi.org/10.1016/j.jval.2015.09.1616
27. Legifrance. JORF n°0298 du 24 décembre 2013 page 21034 - texte n° 3 - LOI n° 2013-1203 du 23 décembre 2013 de financement de la sécurité sociale pour 2014. [Internet]. [cited 2016Oct28]. Available from:https://www.legifrance.gouv.fr/affichTexte.do;jsessionid=451C94702FA3F517186E56A44600EAF7.tpdila16v_2?cidTexte=JORFTEXT000028372809&categorieLien=id
28. Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). Etat des lieux sur les médicaments biosimilaires - Mai 2016. [Internet]. [cited 2016May17]. Available from:http://ansm.sante.fr/S-informer/Actualite/L-ANSM-publie-une-mise-au-point-sur-les-medicaments-biosimilaires-Point-d-Information
29. Legifrance. PLFSS 2017 - Annexe 10 - Fiches d'évaluation préalable des articles du projet de loi. [Internet]. [cited 2016Oct28]. Available from:https://www.legifrance.gouv.fr/content/download/10612/122221/version/2/file/ei_ecfx1623944L_cm_05.10.2016.pdf
30. Fernandez-Lopez S, Kazzaz D, Bashir M, McLaughlin T. Assessment of pharmacists' views on biosimilar naming conventions. J Manag Care Spec Pharm 2015; 21(3):188-95; PMID:25726028; http://dx.doi.org/10.18553/jmcp.2015.21.3.188
31. Alliance for Safe Biologic Medicines (ASBM). ASBM Releases Pharmacist Survey; Findings Show Strong Support for Distinguishable Names for Biologics and Need for Transparency in Labeling. [Internet]. [cited 2016Apr20]. Available from:http://safebiologics.org/resources/2015/10/asbm-releases-pharmacist-survey-findings-show-strong-support-for-distinguishable-names-for-biologics-and-need-for-transparency-in-labeling/
32. Tanabe K, Sugimoto N, Fujimoto Y. A Web-Based Survey to Investigate the Extent of Awareness and Understanding for Biosimilar among Japanese Physicians and Pharmacists. Value Health J Int Soc Pharmacoeconomics Outcomes Res 2015; 18(7):A658; PMID:26533689; http://dx.doi.org/10.1016/j.jval.2015.09.2381
33. er janvier 2015. [Internet]. [cited 2016May17]. Available from:http://www.ordre.pharmacien.fr/Communications/Elements-demographiques/Les-pharmaciens-Panorama-au-1er-janvier-2015
34. Beck M, Michel B, Rybarczyk-Vigouret MC, Levêque D, Sordet C, Sibilia J, Velten M. Rheumatologists' perceptions of biosimilar medicines prescription:findings from a French web-based survey. BioDrugs 2016; 30(6):585-92[epub ahead of print]; PMID:27848166; http://dx.doi.org/10.1007/s40259-016-0202-5
35. Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM). Les médicaments biosimilaires - Etat des lieux Septembre 2013 [Internet]. [cited 2016Apr20]. Available from:http://www.ansm.sante.fr/var/ansm_site/storage/original/application/6187b427efca64d2a15e496ff691158e.pdf
36. Park W, Hrycaj P, Jeka S, Kovalenko V, Lysenko G, Miranda P, Mikazane H, Gutierrez-Ureña S, Lim M, Lee YA, et al. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis:the PLANETAS study. Ann Rheum Dis 2013; 72(10):1605-12; PMID:23687259; http://dx.doi.org/10.1136/annrheumdis-2012-203091
37. Yoo DH, Hrycaj P, Miranda P, Ramiterre E, Piotrowski M, Shevchuk S, Kovalenko V, Prodanovic N, Abello-Banfi M, Gutierrez-Ureña S, et al. A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis:the PLANETRA study. Ann Rheum Dis 2013; 72(10):1613-20; PMID:23687260; http://dx.doi.org/10.1136/annrheumdis-2012-203090
38. Schneider CK. Biosimilars in rheumatology:the wind of change. Ann Rheum Dis 2013; 72:315-8; PMID:23390018; http://dx.doi.org/10.1136/annrheumdis-2012-202941
39. ClinicalTrials.gov. “Efficacy and Safety of Infliximab-biosimilar (Inflectra) Compared to Infliximab-innovator (Remicade) in Patients With Inflammatory Bowel Disease in Remission:the SIMILAR Trial.”. [Internet]. [cited 2016Mar4]. Available from:https://clinicaltrials.gov/ct2/show/NCT02452151
40. Jung YS, Park DI, Kim YH, Lee JH, Seo PJ, Cheon JH, Kang HW, Kim JW. Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease:A retrospective multicenter study. J Gastroenterol Hepatol 2015; 30:1705-12; PMID:25974251; http://dx.doi.org/10.1111/jgh.12997
41. Park SH, Kim YH, Lee JH, Kwon HJ, Lee SH, Park DI, Kim HK, Cheon JH, Im JP, Kim YS, et al. Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea. Expert Rev Gastroenterol Hepatol 2015; 9 Suppl 1:35-44; PMID:26395533; http://dx.doi.org/10.1586/17474124.2015.1091309
42. British Society of Gastroenterology (BSG). Clinical trials updates - PANTS study. [Internet]. [cited 2016Mar4]. Available from:http://www.bsg.org.uk/research/clinical-trials-updates/index.html
43. Nikiphorou E, Kautiainen H, Hannonen P, Asikainen J, Kokko A, Rannio T, Sokka T. Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data. Expert Opin Biol Ther 2015; 15:1677-83; PMID:26549204; http://dx.doi.org/10.1517/14712598.2015.1103733
44. Sieczkowska J, Jarzębicka D, Banaszkiewicz A, Plocek A, Gawronska A, Toporowska-Kowalska E, Oracz G, Meglicka M, Kierkus J. Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations. J Crohns Colitis 2016; 10:127-32; PMID:26721942; http://dx.doi.org/10.1093/ecco-jcc/jjv233
45. ClinicalTrials.gov. The NOR-SWITCH Study. [Internet]. [cited 2016Mar4]. Available from:https://clinicaltrials.gov/ct2/show/NCT02148640
46. Nederlands Trial Register. Trial info - The effect of switching treatment from innovator infliximab to infliximab biosimilar on efficacy, safety and immunogenicity in patients with rheumatoid arthritis, spondyloarthritis or psoriatic arthritis in daily clinical care - BIO-SWITCH study. [Internet]. [cited 2016Mar4]. Available from:http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5279
47. Mysler E, Pineda C, Horiuchi T, Singh E, Mahgoub E, Coindreau J, Jacobs I. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int 2016; 36(5):613-25; PMID:26920148; http://dx.doi.org/10.1007/s00296-016-3444-0
48. World Health Organization. Programme on International Nonproprietary Names (INN)-2015, Biological qualifier:an INN proposal. [Internet]. [cited 2016Oct28]. Available from:http://www.who.int/medicines/services/inn/bq_innproposal201506.pdf.pdf