First monoclonal antibody biosimilars: Tackling the challenge of substitution

Journal of Medical Economics

Volumn 19, Issue 6, 2016, Pages 645-647

  Bocquet, François ^a,b,c   Paubel, Pascal ^a,b,c  

^a UNIVERSITÉ PARIS DESCARTES   (France)

^b INSERM   (France)

^c ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; INFLIXIMAB; MONOCLONAL ANTIBODY; ADALIMUMAB; BEVACIZUMAB; ERYTHROPOIETIN; ETANERCEPT; FILGRASTIM; GRANULOCYTE COLONY STIMULATING FACTOR; GROWTH HORMONE; NEUTRALIZING ANTIBODY; RITUXIMAB;

ANKYLOSING SPONDYLITIS; CLINICAL DECISION MAKING; CLINICAL EFFECTIVENESS; COST EFFECTIVENESS ANALYSIS; CROHN DISEASE; DRUG APPROVAL; DRUG COST; DRUG EFFICACY; DRUG FORMULARY; DRUG MARKETING; DRUG QUALITY; EDITORIAL; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; IMMUNOGENICITY; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PSORIASIS; PSORIATIC ARTHRITIS; RHEUMATOID ARTHRITIS; RISK MANAGEMENT; SEROCONVERSION; THERAPEUTIC EQUIVALENCE; ULCERATIVE COLITIS; DRUG INDUSTRY; DRUG SUBSTITUTION; ECONOMIC ASPECT; ECONOMICS; EUROPE; LEGISLATION AND JURISPRUDENCE; DRUG MANUFACTURE; DRUG SAFETY; EUROPEAN MEDICINES AGENCY;

ANTIBODIES, MONOCLONAL; BIOSIMILAR PHARMACEUTICALS; DRUG INDUSTRY; DRUG SUBSTITUTION; ECONOMIC COMPETITION; EUROPE; HUMANS;

EID: 84964579356     PISSN: 13696998     EISSN: 1941837X     Source Type: Journal    
DOI: 10.1080/13696998.2016.1178649     Document Type: Editorial

References (16)

1. Global medicines use in 2020: outlook and implications. IMS Health for Healthcare Informatics Report, 2015. https://www.imshealth.com/en/thought-leadership/ims-institute/reports/global-medicinesuse-in-2020#ims-form. Accessed February 21, 2016
2. Bocquet F, Paubel P. A long war begins: biosimilars versus patented biologics. J Med Econ 2015;18:1071-3
3. Rickwood S, Di Biase S. Searching for Terra Firma in the Biosimilars and Non-Original Biologics Market - Insights for the coming decade of change. IMS Health Whitepaper, 2013. http://www.imshealth.com/deployedfiles/imshealth/Global/Content/Healthcare/Life%20Sciences%20Solutions/Generics/IMSH_Biosimilars_WP.pdf. Accessed February 21, 2016
4. What you need to know about biosimilar medicinal products: process on corporate responsibility in the field of pharmaceuticals access to medicines in Europe. European Commission. Consensus Information Paper, 2013. http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/biosimilars_report_en.pdf. Accessed January 18, 2016
5. Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues, European Medicines Agency (EMA), EMA/CHMP/BMWP/403543/2010, Committee for Medicinal Products for Human Use (CHMP). 2012. http://www.ema.europa.eu. Accessed February 27, 2016
6. European public assessment reports for Inflectra and Remsima (infliximab). European Medicines Agency (EMA), 2013. http://www.ema.europa.eu. Accessed February 27, 2016
7. The NOR-SWITCH Study. Tore K. Kvien, Diakonhjemmet Hospital. ClinicalTrials.gov Identifier: NCT02148640
8. Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and Safety of CTP13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P 13. San Diego, CA: ACR, 2013. Abstract #L1
9. Park W, Miranda P, Brzosko M, et al. Efficacy and safety of CT-P13 (infliximab Biosimilar) over two years in patients with ankylosing spondylitis: comparison between continuing with CT-P13 and switching from infliximab to CT-P 13. San Diego, CA: ACR, 2013. Abstract #L15
10. Kang YS, Moon HH, Lee SE, et al. Clinical experience of the use of CT-P13, a biosimilar to infliximab in patients with inflammatory bowel disease: a case series. Dig Dis Sci 2015;60:951-6
11. Bocquet F, Fusier I, Cordonnier AL, et al. Budget impact analysis of implementing tenders between the branded infliximab and its biosimilars in the public hospitals of Paris. Value Health 2015;18:A639
12. Reuters - Exclusive: Hospira wins French biosimilar drug tender at 45 pct discount. 2015. http://www.reuters.com/article/us-francebiosimilars-idUSKCN0PD1SI20150707. Accessed February 27, 2016
13. BioPharma-Reporter.com. Biosimilars discounts and switching will wipe-out J&J’s Remicade in Norway, says regulator. 2016. http://www.biopharma-reporter.com/Markets-Regulations/Biosimilar-discountswill-wipe-out-Janssen-s-Remicade-sales-in-Norway. Accessed February 27, 2016
14. National Institute for Health and Care Excellence (NICE). Health technologies adoption programme. Introducing biosimilar versions of infliximab: Inflectra and Remsima. 2015. https://www.nice.org.uk/guidance. Accessed February 27, 2016
15. Food and Drug Administration, CDER and CBER. Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009. Biosimilarity Revision 1. Guidance for Industry. 2015. http://www.fda.gov/downloads/Drugs/…/Guidances/UCM273001.pdf. Accessed February 27, 2016
16. Sandoz US Communication. Novartis - Sandoz launches ZarxioTM (filgrastim-sndz), the first biosimilar in the United States. 2015. https://www.novartis.com/news/media-releases/sandoz-launcheszarxiotm-filgrastim-sndz-first-biosimilar-united-states. Accessed February 27, 2016.