[Biosimilars antibodies: positioning compared to originators - the experience in rheumatology and the biosimilars of trastuzumab in oncology].
Anticorps biosimilaires versus princeps - L’expérience en rhumatologie et les biosimilaires du trastuzumab en oncologie.
Journal
Medecine sciences : M/S
ISSN: 1958-5381
Titre abrégé: Med Sci (Paris)
Pays: France
ID NLM: 8710980
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
entrez:
7
1
2020
pubmed:
7
1
2020
medline:
23
6
2020
Statut:
ppublish
Résumé
Biosimilars have demonstrated their equivalence with biologic originators, according to rigorous specifications imposed by the regulatory agencies, the FDA and the EMA. Their development is justified by the very high cost of biopharmaceuticals, and strong incentives for their prescription lead us to hope substantial savings, allowing to finance other innovative molecules. Trastuzumab marked history of the treatment of breast cancer. Four biosimilars of trastuzumab are available for routine use and we will detail the key points of their development. Anticorps biosimilaires versus princeps - L’expérience en rhumatologie et les biosimilaires du trastuzumab en oncologie. Les biosimilaires sont des produits ayant montré leur équivalence avec le traitement biologique de référence, selon un cahier des charges strict imposé par les agences d’enregistrement, la FDA et l’EMA. Leur développement et leur utilisation sont justifiés par le coût très élevé des biomédicaments, et de fortes incitations à leur prescription font espérer des économies substantielles, permettant le financement d’autres molécules innovantes. Le trastuzumab a marqué l’histoire des traitements du cancer du sein, quatre biosimilaires étant désormais disponibles pour une utilisation en routine. Nous détaillerons ici les points clés de leur développement.
Autres résumés
Type: Publisher
(fre)
Anticorps biosimilaires versus princeps - L’expérience en rhumatologie et les biosimilaires du trastuzumab en oncologie.
Identifiants
pubmed: 31903928
doi: 10.1051/medsci/2019214
pii: msc190225
doi:
Substances chimiques
Antibodies
0
Biosimilar Pharmaceuticals
0
Trastuzumab
P188ANX8CK
Types de publication
Journal Article
Review
Langues
fre
Sous-ensembles de citation
IM
Pagination
1137-1145Informations de copyright
© 2019 médecine/sciences – Inserm.
Références
Guidelines on evaluation of similar biotherapeutic products 5SBPs, 2010; p. 1–34.
European Medecines Agency cfMpfHU. Guideline on similar biological medecinal products containing monoclonal antibodies - non clinical and clinical issues. http://wwwemaeuropaeu/docs/en_GB/document_library/Scientif_guideline/2012/06/WC500128686pdf. 2012.
Agency EM. Guideline on similar biological products containing biotechnology-derived proteins as active sustance: non-clinical and clinical issues. http://wwwemaeuropaeu/docs/en_GB/document_library/Scientif_guideline/2015/01/WC500180219pdf. 2015.
Agencies UEM. Scientific considerations in demonstrating biosimilarity to a reference product, Guidance for Industry. http://wwwfdagov/downloads/drugs/guidanceComplianceRegulatoryInformation/Guidances/UCM291128pdf. 2015.
Vezér B, Buzás Z, Sebeszta M, Zrubka Z. Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents. Curr Med Res Opin 2016 ; 32: 829–834.
Jorgensen KK, Olsen IC, Goll GL, et al. Switching from originatoir infliximab to biosimilar CT-P13 compared with maintained treatment with originator infliximab [NOR-SWITCH]: a 52-week, randomised, double-blind, non-inferiority trial. Lancet 2017 ; 389: 2304–2316.
Glintborg B, Sørensen IJ, Loft AG, et al. A nationwide non-medical switch from originator infliximab to biosimilar CT-P13 in 802 patients with inflammatory arthritis: 1-year clinical outcomes from the DANBIO registry. Ann Rheum Dis 2017 ; 76: 1426–1431.
Agence Nationale de sécurité du médicament et des produits de santé. État des lieux sur les médicaments biosimilaires. Paris: Ansm, 2016: 1–28.
ANSM. Analyse des ventes de médicaments en France en 2013; 2014; p. 1–36 [http://www.ansm.sante.fr/content/download/64305/824219/version/2/file/ANSM.Analyse-Ventes-Medicaments.2013.pdf].
Ghersinick-09072. In: Dépenses de médicaments de l’année 2014 et du premier semestre 2015. Paris: Caisse nationale d’assurance maladie, 2015: 1–24.
Yoo DH, Prodanovic N, Jaworski J, et al. Efficacy and safety of CT-P13 (biosimilar infliximab) in patients with rheumatoid arthritis: comparison between switching from reference infliximab to CT-P13 and continuing CT-P13 in the PLANETRA extension study. Ann Rheum Dis 2017 ; 76: 355–363.
Park W, Yoo DH, Miranda P, et al. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study. Ann Rheum Dis 2017 ; 76: 346–354.
Avouac J, Moltó A, Abitbol V, et al. Systematic switch from innovator infliximab to biosimilar infliximab in inflammatory chronic diseases in daily clinical practice: The experience of Cochin University Hospital, Paris. France. Semin Arthritis Rheum 2018 ; 47: 741–748.
Scherlinger M, Germain V, Labadie C, et al. FHU ACRONIM. Switching from originator infliximab to biosimilar CT-P13 in real-life: the weight of patient acceptance. Joint Bone Spine 2018 ; 85: 561–567.
Arrêté du 3 août 2018 relatif à l’expérimentation pour l’incitation à la prescription hospitalière de médicaments biologiques similaires délivrés en ville. Journal Officiel 17 août 2018.
Arrêté du 12 février 2019 relatif à l’expérimentation pour l’incitation à la prescription hospitalière de médicaments biologiques similaires délivrés en ville. Journal Officiel 15 février 2019.
Hortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med 2005 ; 353: 1734–1736.
Pivot X, Aulagner G, Blay JY, et al. Challenges in the implementation of trastuzumab biosimilars: an expert panel’s recommendations. Anticancer Drugs 2015 ; 26: 1009–1016.
Hurst S, Ryan AM, Ng CK, et al. Comparative nonclinical assessments of the proposed biosimilar PF-05280014 and trastuzumab (Herceptin
Pivot X, Curtit E, Lee YJ, et al. A Randomized phase I pharmacokinetic study comparing biosimilar candidate SB3 and trastuzumab in healthy male subjects. Clin Ther 2016; 38: 1665–73e3.
Pivot X, Deslypere JP, Park LS, Kim MJ, Lee W, Lee J. A randomized phase I study comparing the pharmacokinetics of HD201, a trastuzumab biosimilar, with European Union-sourced herceptin. Clin Ther 2018 ; 40: 396–405 e4.
Esteva FJ, Stebbing J, Wood-Horrall RN, Winkle PJ, Lee SY, Lee SJ. A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab. Cancer Chemother Pharmacol 2018 ; 81: 505–514.
Hanes V, Chow V, Zhang N, Markus R. A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects. Cancer Chemother Pharmacol 2017 ; 79: 881–888.
Morita J, Tanaka M, Nomoto M, et al. Pharmacokinetic bioequivalence, safety, and immunogenicity of DMB-3111, a trastuzumab biosimilar, and trastuzumab in healthy Japanese adult males: results of a randomized trial. BioDrugs 2016 ; 30: 17–25.
Zhou X, Yu J, Wang W, et al. A phase I dose-escalation study of a biosimilar trastuzumab in Chinese metastasis breast cancer patients. Springerplus. 2015 ; 4: 803.
Yin D, Barker KB, Li R, et al. A randomized phase 1 pharmacokinetic trial comparing the potential biosimilar PF-05280014 with trastuzumab in healthy volunteers (REFLECTIONS B327–01). Br J Clin Pharmacol 2014 ; 78: 1281–1290.
Wisman LA, De Cock EP, Reijers JA, et al. A phase I dose-escalation and bioequivalence study of a trastuzumab biosimilar in healthy male volunteers. Clin Drug Investig 2014 ; 34: 887–894.
Bruno R, Washington CB, Lu JF, Lieberman G, Banken L, Klein P. Population pharmacokinetics of trastuzumab in patients with HER2+ metastatic breast cancer. Cancer Chemother Pharmacol 2005 ; 56: 361–369.
Leyland-Jones B, Gelmon K, Ayoub JP, et al. Pharmacokinetics, safety, and efficacy of trastuzumab administered every three weeks in combination with paclitaxel. J Clin Oncol 2003 ; 21: 3965–3971.
von Minckwitz G, Colleoni M, Kolberg HC, et al. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial. Lancet Oncol 2018 ; 19: 987–998.
Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol 2017 ; 18: 917–928.
Pivot X, Bondarenko I, Nowecki Z, et al. Phase III, randomized, double-blind study comparing the efficacy, safety, and Immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients treated with neoadjuvant therapy for human epidermal growth factor receptor 2-positive early breast cancer. J Clin Oncol 2018 ; 36: 968–974.
Lammer P, Dank M, Masetti R, et al. Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breaast cancer. Br J Cancer 2018 ; 119: 266–273.
Pivot X, Thierry-Vuillemin A, Villanueva C, Bazan F. Response rates: a valuable signal of promising activity?. Cancer J 2009 ; 15: 361–365.
Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet. 2014 ; 384: 164–172.
Pivot X, Cox DG. A new era for treatment development in HER2-positive breast cancer. Lancet Oncol 2018 ; 19: 160–162.
Rugo HS, Barve A, Waller CF, et al. Effect of a proposed trastuzumab biosimilar compared with Trastuzumab on Overall Response Rate in Patients With ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Randomized Clinical Trial. JAMA 2017 ; 317: 37–47.
Pegram M, Tan-Chui E, Freyman A, et al. A randomized, double blind study of PF-05280014 (a potential trastuuzmab biosimilar) vs trastuzumab, both in combination with paclitaxel, as first-line treatment for HER2-positive metastatic breast canecr. European Society forMedical Oncology (ESMO). 2017.
Pivot X, Bondarenko I, Nowecki Z, et al. A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: final safety, immunogenicity and survival results. Eur J Cancer 2018 ; 93: 19–27.
Kim S, Song J, Park S, et al. Drifts in ADCC-related quality attributes of Herceptin(R): Impact on development of a trastuzumab biosimilar. MAbs 2017 ; 9: 704–714.
Pivot X, Petit T. Can we establish a hierarchy among trastuzumab biosimilar candidates?. Br J Cancer 2018 ; 119: 263–265.