Switching to biosimilar infliximab (CT-P13): Evidence of clinical safety, effectiveness and impact on public health
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Abraham, 2013, Developing oncology biosimilars: an essential approach for the future, Semin Oncol, 40, S5, 10.1053/j.seminoncol.2013.09.015
Rinaudo-Gaujous, 2013, Review article: biosimilars are the next generation of drugs for liver and gastrointestinal diseases, Aliment Pharmacol Ther, 38, 914, 10.1111/apt.12477
Haustein, 2012, Saving money in the European healthcare systems with biosimilars, Generics Biosimilars Initiat J, 1, 120, 10.5639/gabij.2012.0103-4.036
Rand corporation, 2014
EMA, 2014
FDA, 2015
WHO, 2009
GABI, 2011
Chow, 2013, Assessing biosimilarity and interchangeability of biosimilar products, Stat Med, 32, 316
FDA, 2015
Tóthfalusi, 2014, Statistical and regulatory considerations in assessments of interchangeability of biological drug products, Eur J Health Econ, 15, S5, 10.1007/s10198-014-0589-1
Ebbers, 2012, Interchangeability, immunogenicity and biosimilars, Nat Biotechnol, 30, 1186, 10.1038/nbt.2438
SCRIP, 2015
GABI, 2015
GABI, 2014
EBE, 2014
GABI, 2015
GABI, 2012
PEI, 2015
Grigor, 2004, Effect of a treatment strategy of tight control for rhuematoid arthritis (the TICORA study): a single-blind randomised controlled trial, Lancet, 23, 263, 10.1016/S0140-6736(04)16676-2
Goekoop-Ruiterman, 2005, Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomized, controlled trial, Arthritis Rheum, 52, S126
Smolen, 2014, EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update, Ann Rheum Dis, 73, 492, 10.1136/annrheumdis-2013-204573
Mowat, 2011, Guidelines for the management of inflammatory bowel disease in adults, Gut, 60, 571, 10.1136/gut.2010.224154
Singh, 2012, 2012 update of the 2008 American college of rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis, Arthritis Care Res Hob, 64, 625, 10.1002/acr.21641
Van Assche, 2012, Switch to adalimumab in patients with Crohn's disease controlled by maintenance infliximab: prospective randomised SWITCH trial, Gut, 61, 229, 10.1136/gutjnl-2011-300755
Lie, 2011, Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register, Ann Rheum Dis, 70, 157, 10.1136/ard.2010.131797
Bartelds, 2010, Anti-infliximab and anti-adalimumab antibodies in relation to response to adalimumab in infliximab switchers and anti-tumour necrosis factor naive patients: a cohort study, Ann Rheum Dis, 69, 817, 10.1136/ard.2009.112847
Jamnitski, 2011, The presence or absence of antibodies to infliximab or adalimumab determines the outcome of switching to etanercept, Ann Rheum Dis, 70, 284, 10.1136/ard.2010.135111
Virkki, 2011, Outcomes of switching anti-TNF drugs in rheumatoid arthritis—a study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN), Clin Rheumatol, 30, 1447, 10.1007/s10067-011-1779-1
Chatzidionysiou, 2015, Effectiveness of TNF inhibitor switch in RA: results from the national Swedish register, Ann Rheum Dis, 74, 890, 10.1136/annrheumdis-2013-204714
Fagerli, 2013, Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study, Ann Rheum Dis, 72, 1840, 10.1136/annrheumdis-2012-203018
Hyrich, 2007, Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study, Arthritis Rheum, 56, 13, 10.1002/art.22331
Harrold, 2015, The comparative effectiveness of abatacept versus anti-tumour necrosis factor switching for rheumatoid arthritis patients previously treated with an anti-tumour necrosis factor, Ann Rheum Dis, 74, 430, 10.1136/annrheumdis-2013-203936
Finckh, 2007, B cell depletion may be more effective than switching to an alternative anti-tumor necrosis factor agent in rheumatoid arthritis patients with inadequate response to anti-tumor necrosis factor agents, Arthritis Rheum, 56, 1417, 10.1002/art.22520
Gomez-Reino, 2012, Comparative effectiveness of switching to alternative tumour necrosis factor (TNF) antagonists versus switching to rituximab in patients with rheumatoid arthritis who failed previous TNF antagonists: the MIRAR study, Ann Rheum Dis, 71, 1861, 10.1136/annrheumdis-2012-201324
Kekow, 2012, Rituximab is more effective than second anti-TNF therapy in rheumatoid arthritis patients and previous TNFα blocker failure, Biologics, 6, 191
Blom, 2011, Effectiveness of a third tumor necrosis factor-α-blocking agent compared with rituximab after failure of 2 TNF- blocking agents in rheumatoid arthritis, J Rheumatol, 38, 2355, 10.3899/jrheum.101324
Navarro Coy, 2014, The 'Switch' study protocol: a randomised-controlled trial of switching to an alternative tumour-necrosis factor (TNF)-inhibitor drug or abatacept or rituxi mab in patients with rheumatoid arthritis who have failed an initial TNF-inhibitor drug, BMC Musculoskelet Disord, 15, 452, 10.1186/1471-2474-15-452
Weise, 2014, Biosimilars: the science of extrapolation, Blood, 124, 3191, 10.1182/blood-2014-06-583617
Devlin, 2013, Overview of subsequent entry biologics for the management of inflammatory bowel disease and Canadian Association of Gastroenterology position statement on subsequent entry biologics, Can J Gastroenterol, 27, 567, 10.1155/2013/327120
Feagan, 2014, The challenge of indication extrapolation for infliximab biosimilars, Biologicals, 42, 177, 10.1016/j.biologicals.2014.05.005
Maini, 1999, Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoidarthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group, Lancet, 354, 1932, 10.1016/S0140-6736(99)05246-0
Su, 2003, Influence of immunogenicity on the long-term efficacy of infliximab in Crohn's disease, Gastroenterology, 125, 1544, 10.1016/j.gastro.2003.05.009
Anderson, 2005, Tumor necrosis factor inhibitors: clinical implications of their different immunogenicity profiles, Semin Arthritis Rheum, 34, 19, 10.1016/j.semarthrit.2005.01.005
Bendtzen, 2006, Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor α inhibitor infliximab, Arthritis Rheum, 54, 3782, 10.1002/art.22214
Wolbink, 2006, Development of anti-infliximab antibodies and relationship to clinical response in patients with rheumatoid arthritis, Arthritis Rheum, 54, 711, 10.1002/art.21671
Yoo, 2013, 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, 72, 1613, 10.1136/annrheumdis-2012-203090
EMA, 2013
Ebbersa, 2012, The safety of switching between therapeutic proteins, Expert Opin Biol Ther, 12, 1473, 10.1517/14712598.2012.711308
Kropshofer, 2006, Overview of cell-based tools for pre-clinical assessment of immunogenicity of biotherapeutics, J Immunotoxicol, 3, 131, 10.1080/15476910600845625
Jawa, 2013, T-cell dependent immunogenicity of protein therapeutics: preclinical assessment and mitigation, Clin Immunol, 149, 534, 10.1016/j.clim.2013.09.006
Ben-Horin, 2015, Cross-immunogenicity: antibodies to infliximab in Remicade-treated patients with IBD similarly recognise the biosimilar Remsima, Gut
Calvo, 2014, EU's new pharmacovigilance legislation: considerations for biosimilars, Drug Saf, 37, 125, 10.1007/s40264-013-0130-y
McCamish, 2012, The state of the art in the development of biosimilars, Clin Pharmacol Ther, 91, 405, 10.1038/clpt.2011.343
Casadevall, 2013, Pharmacovigilance and biosimilars: considerations, needs and challenges, Expert Opin Biol Ther, 13, 1039, 10.1517/14712598.2013.783560
Ahmed, 2012, Biosimilars: impact of biologic product life cycle and european experience on the regulatory trajectory in the United States, Clin Ther, 34, 400, 10.1016/j.clinthera.2011.12.005
Vermeer, 2013, Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA adverse event reporting system (FAERS) and EudraVigilance databases, Drug Saf, 36, 617, 10.1007/s40264-013-0073-3
Flodmark, 2013, Switching from originator to Biosimilar human growth hormone using dialogue teamwork: single-center experience from Sweden, Biol Ther, 3, 35, 10.1007/s13554-013-0011-z
Lefrère, 2011, First experience of autologous peripheral blood stem cell mobilization with biosimilar granulocyte colony-stimulating factor, Adv Ther, 28, 304, 10.1007/s12325-011-0009-1
Ianotto, 2012, Experience (1 year) of G-CSF biosimilars in PBSCT for lymphoma and myeloma patients, Bone Marrow Transpl, 47, 874, 10.1038/bmt.2011.189
Publicover, 2013, Use of a biosimilar granulocyte colony-stimulating factor for peripheral blood stem cell mobilization: an analysis of mobilization and engraftment, Br J Haematol, 162, 107, 10.1111/bjh.12345
Gascón, 2013, Clinical experience with Zarzio® in Europe: what have we learned?, Support Care Cancer, 21, 2925, 10.1007/s00520-013-1911-7
EMA, 2007
EMA, 2007
Haag-Weber, 2009, Therapeutic equivalence, long-term efficacy and safety of HX575 in the treatment of anemia in chronic renal failure patients receiving hemodialysis, Clin Nephrol, 72, 380
Wizemann, 2008, Comparison of the therapeutic effects of epoetin zeta to epoetin alfa in the maintenance phase of renal anaemia treatment, Curr Med Res Opin, 24, 625, 10.1185/030079908X273264
Davis-Ajami, 2014, Epoetin zeta in the management of anemia associated with chronic kidney disease, differential pharmacology and clinical utility, Biologics, 8, 155
Więcek, 2010, Switching epoetin alfa and epoetin zeta in patients with renal anemia on dialysis: posthoc analysis, Adv Ther, 27, 941, 10.1007/s12325-010-0080-z
Hörbrand, 2013, A population-based study comparing biosimilar versus originator erythropoiesis-stimulating agent consumption in 6,117 patients with renal anaemia, Eur J Clin Pharmacol, 69, 929, 10.1007/s00228-012-1412-5
Jung, 2014, Physicochemical characterization of Remsima, MAbs, 6, 1163, 10.4161/mabs.32221
Park, 2013, 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, 72, 1605, 10.1136/annrheumdis-2012-203091
Takeuchi, 2015, Evaluation of the pharmacokinetic equivalence and 54-week efficacy and safety of CT-P13 and innovator infliximab in Japanese patients with rheumatoid arthritis, Mod Rheumatol, 25, 817, 10.3109/14397595.2015.1022297
Yoo, 2013, Efficacy and safety of CT-P13 (infliximab biosimilar) over two years in patients with rheumatoid arthritis: comparison between continued CT-P13 and switching from infliximab to CT-P13, Arthritis Rheum, 65, 3319
Park, 2013, 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-P13, Arthritis Rheum, 65, 3326
Brown, 2016, Efficacy and safety of switching from reference infliximab to CT-P13 compared to maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS, Arthritis Rheum
Jung, 2015, Efficacy and safety of CT-P13, a biosimilar of infliximab, in patients with inflammatory bowel disease: a retrospective multicenter study, J Gastroenterol Hepatol, 10.1111/jgh.12997
Park, 2015, Post-marketing study of biosimilar infliximab (CT-P13) to evaluate its safety and efficacy in Korea, Expert Rev Gastroenterol Hepatol, 9, 35, 10.1586/17474124.2015.1091309
Kang, 2015, Clinical experience of the use of CT-P13, a Biosimilar to Infliximab in patients with inflammatory Bowel disease: a case series, Dig Dis Sci, 60, 951, 10.1007/s10620-014-3392-z
Joanna, 2015, Switching between infliximab originator and biosimilar in pediatric patients with inflammatory bowel disease. Preliminary observation, J Crohns Colitis
Nikiphorou, 2015, 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, 15, 1677, 10.1517/14712598.2015.1103733
BioPharma
Danese, 2014, Viewpoint: knowledge and viewpoints on biosimilar monoclonal antibodies among members of the European Crohn's and Colitis Organization, J Crohns Colitis, 8, 1548, 10.1016/j.crohns.2014.06.007
Fonseca, 2014, The Portuguese Society of Rheumatology position paper on the use of biosimilars, Acta Reumatol Port, 39, 60
Mularczyk, 2014, Biosimilar medicines – their use in the treatment of inflammatory bowel diseases. Position statement of the working group of the Polish National Consultant in Gastroenterology, Prz Gastroenterol, 9, 1
Zelenetz, 2011, NCCN Biosimilars white paper: regulatory, scientific, and patient safety perspectives, J Natl Compr Canc Netw, 9, S1
Jahnsen, 2015, Biosimilar infliximab (CT-P13) in the treatment of inflammatory bowel disease: a Norwegian observational study, Expert Rev Gastroenterol Hepatol, 9, 45, 10.1586/17474124.2015.1091308
Gecse, 2015, Efficacy and safety of the Biosimilar Infliximab CT-P13 treatment in inflammatory bowel diseases: a prospective, multicentre, nationwide cohort, J Crohns Colitis
GABI, 2015
Gulácsi, 2015, Biosimilars for the management of rheumatoid arthritis: economic considerations, Expert Rev Clin Immunol, 11, S43, 10.1586/1744666X.2015.1090313
Jha, 2015, The budget impact of biosimilar infliximab (Remsima®) for the treatment of autoimmune diseases in five European countries, Adv Ther, 32, 742, 10.1007/s12325-015-0233-1
Brodszky, 2015, A budget impact model for biosimilar infliximab in Crohn's disease in Bulgaria, the Czech Republic, Hungary, Poland, Romania and Slovakia, Expert Rev Pharmacoecon Outcomes Res, 1, 10.1586/14737167.2015.1067142
Kim, 2014, 5 year budget impact analysis of biosimilar infliximab for the treatment of rheumatoid arthritis in UK, Italy, France and Germany
Brodszky, 2014, 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, 15, S65, 10.1007/s10198-014-0595-3
Baji, 2016, Treatment preferences of originator vs. biosimilar drugs in Crohn's disease; discrete choice experiment among gastroenterologists, Scand J Gastroenterol, 51, 22, 10.3109/00365521.2015.1054422
Rencz, 2015, Biological therapy in inflammatory bowel diseases: access in Central and Eastern Europe, World J Gastroenterol, 21, 1728, 10.3748/wjg.v21.i6.1728
McCarthy, 2013, Introduction of an infliximab biosimilar (CT-P13): a five-year budget impact analysis for the treatment of rheumatoid arthritis in Ireland, Value Health, 16, A558, 10.1016/j.jval.2013.08.1465
NICE, 2015
NICE, 2015