Connaissances et perceptions des médicaments biosimilaires par les professionnels de santé en Tunisie
Tài liệu tham khảo
Mellstedt, 2013, Clinical considerations for biosimilar antibodies, Eur J Cancer Suppl, 11, 1, 10.1016/S1359-6349(13)70001-6
Farhat, 2018, The concept of biosimilars: from characterization to evolution-a narrative review, The Oncologist, 23, 346, 10.1634/theoncologist.2017-0126
Direction de la Pharmacie et du Médicament, 2018, 7
Beck, 2017, Knowledge, behaviors and practices of community and hospital pharmacists towards biosimilar medicines: results of a French web-based survey, MAbs, 9, 384, 10.1080/19420862.2016.1267087
O’Callaghan, 2017, Assessing awareness and attitudes of healthcare professionals on the use of biosimilar medicines: A survey of physicians and pharmacists in Ireland, Regul Toxicol Pharmacol, 88, 252, 10.1016/j.yrtph.2017.06.013
EuropeanMedicines Agency, 2018, 12
Karateev, 2019, Evaluation of physicians’ knowledge and attitudes towards biosimilars in Russia and issues associated with their prescribing, Biomolecules, 9, 57, 10.3390/biom9020057
Dolinar, 2018, A guide to follow-on biologics and biosimilars with a focus on Insulin, Endocr Pract, 24, 195, 10.4158/EP161728.RA
Adé, 2017, A survey of pharmacists’ knowledge and views of biosimilars in Quebec and France, Ann Pharm Fr, 75, 267, 10.1016/j.pharma.2017.01.003
Hadoussa, 2020, Perception of hematologists and oncologists about the biosimilars: a prospective Tunisian study based on a survey, J Oncol Pharm Pract, 26, 124, 10.1177/1078155219848817
Tinsley, 2018, Potential of biosimilars to increase access to biologics: considerations for advanced practice providers in oncology, J Adv Pract Oncol, 9, 699
Weise, 2012, Biosimilars: what clinicians should know, Blood, 120, 5111, 10.1182/blood-2012-04-425744
Dingermann, 2016, Biosimilar epoetin zeta: extrapolation of indications and real world utilization experience, Expert Opin Biol Ther, 16, 967, 10.1080/14712598.2016.1194822
Weise, 2014, Biosimilars: the science of extrapolation, Blood, 124, 3191, 10.1182/blood-2014-06-583617
EuropeanMedicines Agency, 2016
European Medicines Agency, 2017, 2
Agarwal, 2016, Understanding the biosimilar approval and extrapolation process—A case study of an epoetin biosimilar, Crit Rev Oncol Hematol, 104, 98, 10.1016/j.critrevonc.2016.04.016
Ebbers, 2016, Controversies in establishing biosimilarity: extrapolation of indications and global labeling practices, BioDrugs, 30, 1, 10.1007/s40259-015-0154-1
Gascon, 2019, Extrapolation in practice: lessons from 10 years with biosimilar filgrastim, BioDrugs, 33, 635, 10.1007/s40259-019-00373-2
Barbier, 2020, The efficacy, safety, and immunogenicity of switching between reference biopharmaceuticals and biosimilars: a systematic review, Clin Pharmacol Ther, 108, 734, 10.1002/cpt.1836
Trifirò, 2018, Interchangeability of biosimilar and biological reference product: updated regulatory positions and pre- and post-marketing evidence, Expert Opin Biol Ther, 18, 309, 10.1080/14712598.2018.1410134
Macdonald, 2015, Regulatory considerations in oncologic biosimilar drug development, MAbs, 7, 653, 10.1080/19420862.2015.1040973
Crommelin, 2015, The similarity question for biologicals and non-biological complex drugs, Eur J Pharm, 76, 10, 10.1016/j.ejps.2015.04.010
Rugo, 2016, A clinician's guide to biosimilars in oncology, Cancer Treat Rev, 46, 73, 10.1016/j.ctrv.2016.04.003
Rak Tkaczuk, 2014, Biosimilars in oncology: from development to clinical practice, Semin Oncol, 41, S3, 10.1053/j.seminoncol.2014.03.008
Niederwieser, 2011, Biosimilar agents in oncology/haematology: from approval to practice: Biosimilars in oncology/haematology, Eur J Haematol, 86, 277, 10.1111/j.1600-0609.2010.01566.x
Bocquet, 2016, First monoclonal antibody biosimilars: tackling the challenge of substitution, J Med Econ, 19, 645, 10.1080/13696998.2016.1178649
Commission des médicaments biologiquement similaires, 2021, 1
US Food and Drug Administration, 2012, Guidance for industry: biosimilars: questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009, US Food and Drug Administration, 19
Food Drug Administration, 2015, 9
Minghetti, 2012, The regulatory framework of biosimilars in the European Union, Drug Discov Today, 17, 63, 10.1016/j.drudis.2011.08.001
Moreau, 2013
Jørgensen, 2017, Switching from originator infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab (NOR-SWITCH): a 52-week, randomised, double-blind, non-inferiority trial, The Lancet, 389, 2304, 10.1016/S0140-6736(17)30068-5
Lamanna, 2017, The structure-function relationship of disulfide bonds in etanercept, Sci Rep, 7, 3951, 10.1038/s41598-017-04320-5
Dutta, 2020, Identifying key benefits in european off-patent biologics and biosimilar markets: it is not only about price!, BioDrugs, 34, 159, 10.1007/s40259-019-00395-w
de Mora, 2019, Biosimilars: a value proposition, BioDrugs, 33, 353, 10.1007/s40259-019-00360-7
Khemakhem, 2021, 24
Choy, 2014, Biosimilar safety considerations in clinical practice, Semin Oncol, 41, S3, 10.1053/j.seminoncol.2013.12.001
Declerck, 2013, Biosimilar monoclonal antibodies: a science-based regulatory challenge, Expert Opin Biol Ther, 13, 153, 10.1517/14712598.2012.758710
Schellekens, 2005, Factors influencing the immunogenicity of therapeutic proteins, Nephrol Dial Transplant, 20, vi3, 10.1093/ndt/gfh1092
Pouillon, 2018, The nocebo effect: a clinical challenge in the era of biosimilars, Expert Rev Clin Immunol, 14, 739, 10.1080/1744666X.2018.1512406
