Evaluation of efficacy and comparative frequency of adverse events in patients with ulcerative colitis receiving the original infliximab and its biosimilar. One year of observation
- 作者: Knyazev O1, Shkurko T1,2, Kagramanova A1, Lishchinskaya A1, Zvyaglova M1, Korneeva I1, Babayan A1, Parfenov A1
-
隶属关系:
- Loginov Moscow Clinical Scientific Center
- Research Institute of Health Organization and Medical Management
- 期: 卷 91, 编号 8 (2019)
- 页面: 41-46
- 栏目: Editorial
- URL: https://journals.rcsi.science/0040-3660/article/view/33603
- DOI: https://doi.org/10.26442/00403660.2019.08.000331
- ID: 33603
如何引用文章
全文:
详细
作者简介
O Knyazev
Loginov Moscow Clinical Scientific Centerд.м.н., зав. отд-нием воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
T Shkurko
Loginov Moscow Clinical Scientific Center; Research Institute of Health Organization and Medical Managementк.м.н., зав. организационно-методическим отделом по гастроэнтерологии ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
A Kagramanova
Loginov Moscow Clinical Scientific Centerк.м.н., с.н.с. отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
A Lishchinskaya
Loginov Moscow Clinical Scientific Centerк.м.н., с.н.с. отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
M Zvyaglova
Loginov Moscow Clinical Scientific Centerм.н.с отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
I Korneeva
Loginov Moscow Clinical Scientific Centerврач гастоэнтеролог отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
A Babayan
Loginov Moscow Clinical Scientific Centerврач гастоэнтеролог отд-ния воспалительных заболеваний кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
A Parfenov
Loginov Moscow Clinical Scientific Center
Email: asfold@mail.ru
д.м.н., проф., зав. отд. патологии кишечника ГБУЗ «МКНЦ им. А.С. Логинова ДЗМ» Moscow, Russia
参考
- FDA Guidance for Industry. Scientific considerations in demonstrating bio - similarity to a reference product. 2015.
- Declerck P, Danesi R, Petersel D, Jacobs I. The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs. 2017;77(6):671-7.
- EMA. Guideline on similar biological medicinal products. 2014. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768
- Yamaguchi T, Arato T. Quality, safety and efficacy of follow - on biologies in Japan. Biologicals. 2011;39(5):328-32.
- Jacobs I, Petersel D, Shane L.G, Ng C.K, Kirchhoff C, Finch G, et al. Monoclonal antibody and fusion protein biosimilars across therapeutic areas: a systematic review of published evidence. BioDrugs. 2016;30(6):489-523.
- Comparability of biotechnological/biological products subject to changes in their manufacturing process. Available from: https://www.pmda.go.jp/files/ 000156658.pdf
- Biosimilars in the EU. 2017. Available from: http://www.ema.europa.eu/docs/en_GB/documentJibrary/Leaflet/2017/05/WC50Q226648.pdf
- EMA Guideline. Similar biological medicinal products containing biotechnology - derived proteins as active substance: non - clinical and clinical issues. 2015. Available from: http://www.ema.europa.eu/docs/en_GB/documentJibrary/Scientific_guideline/2015/01 /WC500180219.pdf
- Ивашкин В.Т., Шелыгин Ю.А., Халиф И.Л., Белоусова Е.А. и др. Клинические рекомендации Российской гастроэнтерологической ассоциации и Ассоциации колопроктологов России по диагностике и лечению язвенного колита. Колопроктология. 2017;59(1):6-30.
- Brown S.R, Haboubi N, Hampton J, George B, Travis S.P. The management of acute severe colitis: ACPGBI position statement. Colorectal Dis. 2008;(10):8-29.
- Mokhele N.N, Tomson S.R, Watermeyer G.A. Predictors of emergency colectomy in patients admitted with acute severe ulcerative colitis. S Afr J Surg. 2017 Sep;55(3):20-6.
- Øresland T, Bemelman W.A, Sampietro G.M, Spinelli A, Windsor A, Ferrante M, Marteau P, Zmora O, Kotze P.G, Espin-Basany E, et al. European evidence based consensus on surgery for ulcerative colitis. J Crohn's Colitis. 2015 Jan;9(1):4-25. doi: 10.1016/j.crohns.2014.08.012
- Biosimilars in the EU. Available from: https://www.ema.europa.eu/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf.
- Biosimilars action plan: balancing innovation and competition. 2018. Available from: https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm613761.pdf