Addressing the health technology assessment of biosimilar pharmaceuticals

References

• Draborg E, Gyrd-Hansen D, Poulsen PB, et al. International comparison of the definition and the practical application of health technology assessment. Int J Technol Assess Health Care 2005;21:89-95
   PubMed Web of Science ®Google Scholar
• Directions and Consolidating Directions to the National Institute for Health and Clinical Excellence 2005. http://www.nice.org.uk/niceMedia/pdf/DirectionFromSecretaryOfState2005.pdf Accessed 15/2/10
   Google Scholar
• Taylor RS, Drummond MF, Salkeld G, et al. Inclusion of cost effectiveness in licensing requirements of new drugs: the fourth hurdle. BMJ 2004;329:972-5
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Evidence. Bevacizumab and Cetuximab for the treatment of metastatic colorectal cancer (TA118). http://guidance.nice.org.uk/TA118/Guidance Accessed 21/06/10
   Google Scholar
• National Institute for Health and Clinical Evidence. Breast cancer (advanced or metastatic) - lapatinib: final appraisal determination http://www.nice.org.uk/nicemedia/live/11731/49197/49197.pdf. Accessed 21/06/10
   Google Scholar
• European Agency for the Evaluation of Medicinal Products. EMEA/CPMP position statement on the use of placebo in clinical trials with regard to the revised Declaration of Helsinki. http://www.emea.europa.eu/pdfs/human/press/pos/1742401en.pdf. Accessed 10/11/09
   Google Scholar
• US Food and Drug Administration. Drug study designs. http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm117847.htm. Accessed 10/11/09
   Google Scholar
• Scottish Medicines Consortium. Guidance to Manufacturers for Completion of New Product Assessment Form (NPAF) (Revised June 2007). http://www.scottishmedicines.org.uk/smc/22.html. Accessed 10/11/09
   Google Scholar
• National Institute for Health and Clinical Excellence. Single technology appraisal (STA) Specification for manufacturer/sponsor submission of evidence. http://www.nice.org.uk/aboutnice/howwework/devnicetech/technologyappraisalprocessguides/singletechnologyappraisalsprocess/reviewofthespecificationformanufacturersponsorsubmissionofevidence.jsp?domedia=1&mid=D2688DBA-19B9-E0B5-D4B2FB72AF92D6FC. Accessed 10/11/09
   Google Scholar
• All Wales Medicines Strategy Group. Guidance notes to manufacturers on the completion of the therapeutic development appraisal. http://www.wales.nhs.uk/sites3/page.cfm?orgid=371&pid=37512. Accessed 10/11/09
   Google Scholar
• European Commission. Chapter 1 Marketing Authorisation. Volume 2a: Procedures for marketing authorisation. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/a/vol2a_chap1_2005-11.pdf. Accessed 10/11/09
   Google Scholar
• Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol 2008;19:411-19
   PubMed Web of Science ®Google Scholar
• British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. BNF 59 March 2010
   Google Scholar
• Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res 2007;30:267-72
   PubMed Web of Science ®Google Scholar
• European Agency for the Evaluation of Medicinal Products. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. http://www.emea.europa.eu/pdfs/human/biosimilar/4283205en.pdf. Accessed 10/11/09
   Google Scholar
• Giezen TJ, Mantel-Teeuwisse AK, Straus SM, et al. Safety related regulatory actions for biologicals approved in the United States and the European Union. JAMA 2008;300:1887-96
   PubMed Web of Science ®Google Scholar
• Vanz AL, Renard G, Palma MS, et al. Human granulocyte colony stimulating factor (hG-CSF): cloning, overexpression, purification and characterization. Microb Cell Fact 2008;7:13-24
   PubMed Web of Science ®Google Scholar
• European Agency for the Evaluation of Medicinal Products CHMP assessment report for Filgrastim Ratiopharm: EMEA/H/C/824. www.emea.europa.eu/humandocs/PDFs/EPAR/filgrastimratiopharm/H-824-en6.pdf. Accessed 10/11/09
   Google Scholar
• European Agency for the Evaluation of Medicinal Products. CHMP assessment report for Filgrastim Hexal: EMEA/H/C/918. www.emea.europa.eu/humandocs/PDFs/EPAR/FilgrastimHexal/H-918-en6.pdf. Accessed 10/11/09
   Google Scholar
• Scottish Medicines Consortium. Minutes of meeting on 9/10/09: Item 8.8. http://www.scottishmedicines.org.uk/smc/7361.html. Accessed 10/11/09
   Google Scholar
• National Information Center on Health Services Research and Health Care Technology (NICHSR). Glossary of frequently encountered terms in health economics. http://www.nlm.nih.gov/nichsr/edu/healthecon/glossary.html Accessed 15/2/10
   Google Scholar
• Mason JM. Cost-per-QALY league tables: their role in pharmacoeconomic analysis. Pharmacoeconomics 1994;5:472-81
   PubMed Web of Science ®Google Scholar
• Schwappach DL. Resource allocation, social values and the QALY: a review of the debate and empirical evidence. Health Expect 2002;5:210-22
   PubMedGoogle Scholar
• Scuffham PA, Whitty JA, Mitchell A, et al. The use of QALY weights for QALY calculations: a review of industry submissions requesting listing on the Australian Pharmaceutical Benefits Scheme 2002-4. Pharmacoeconomics 2008;26:297-310
   PubMed Web of Science ®Google Scholar
• Mortimer D, Segal L. Comparing the incomparable? A systematic review of competing techniques for converting descriptive measures of health status into QALY-weights. Med Decis Making 2008;28:66-89
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Excellence. Appraising life-extending, end of life treatments. www.nice.org.uk/media/E4A/79/SupplementaryAdviceTACEoL.pdf. Accessed 15/2/10
   Google Scholar
• Robinson R. Costs and cost-minimisation analysis. BMJ 1993;307:726-8
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Excellence Guide to the methods of health technology appraisal. http://www.nice.org.uk/niceMedia/pdf/TAP_Methods.pdf. Accessed 10/11/09
   Google Scholar
• Scottish Medicines Consortium. Guidance No. 577/09. http://www.scottishmedicines.org.uk/files/filgrastim%20(Ratiograstim)%20FINAL%20Oct%202009%20Revised%20031109.doc%20for%20website.pdf. Accessed 10/11/09
   Google Scholar
• All Wales Medicines Strategy Group. Advice No. 1609. http://www.wales.nhs.uk/sites3/Documents/371/filgrastim%20%28ratiograstim%29%20FAR.pdf. Accessed 10/11/09
   Google Scholar
• Del GA, Eniu A, Ganea-Motan D, et al. XM02 is superior to placebo and equivalent to Neupogen in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy. BMC Cancer 2008;8:332-8
   PubMed Web of Science ®Google Scholar
• Eldar-Lissai A, Cosler LE, Culakova E, et al. Economic analysis of prophylactic pegfilgrastim in adult cancer patients receiving chemotherapy. Value Health 2008;11:172-9
   PubMed Web of Science ®Google Scholar
• Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol 2005;23:1178-84
   PubMed Web of Science ®Google Scholar
• Kuderer NM, Dale DC, Crawford J, Lyman GH. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol 2007;25:3158-67
   PubMed Web of Science ®Google Scholar
• Zinzani PL, Pavone E, Storti S, et al. Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma. Blood 1997;89:3974-9
   PubMed Web of Science ®Google Scholar
• Groves L, Orchard K, Casey P, et al. Biosimilar filgrastim for peripheral blood stem cell (PBSC) mobilisation prior to autologous stem cell transplantation. An audit of the Southampton University Hospitals NHS Trust (SUHT) Experience British Oncology Pharmacy Association (BOPA) 12th annual symposium, Brighton 16–18 October 2009
   Google Scholar
• Engert A, Griskevicius L, Zyuzgin Y, et al. XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk Lymphoma 2009;50:374-9
   PubMed Web of Science ®Google Scholar
• Gatzemeier U, Ciuleanu T, Dediu M, et al. XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy. J Thorac Oncol 2009;4:736-40
   PubMed Web of Science ®Google Scholar