Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison

Journal
Regulatory Toxicology and Pharmacology
ISSN
0273-2300
Date Issued
2023
Author(s)
Fernanda Lacerda da Silva Machado
Martín Cañás
Svetlana V. Doubova
Martín A. Urtasun
Gustavo H. Marín
Claudia Garcia Serpa Osorio-de-Castro
Flavia Caixeta Albuquerque
Tatiane Bonfim Ribeiro
Lisa Pont
José Crisóstomo Landeros
Juan Roldán Saelzer
Angela Acosta
Manuel A. Machado Beltrán
Lily Iracema Gordillo Alas
Lourdes Abigail Orellana Tablas
Ria Benko
Irma Convertino
Marco Bonaso
Marco Tuccori
Ursula Kirchmayer
Saúl E. Contreras Sánchez
L. Yesenia Rodríguez-Tanta
Ysabel Gutierrez Aures
Boya Lin
Golnoosh Alipour-Haris
Efe Eworuke
Luciane Cruz Lopes
Type
Resource Types::text::journal::journal article
Scopus ID
2-s2.0-85170417399
WoS ID
WOS:001077661800001
DOI
URL
Cite this document
Machado, F. L. D. S., Cañás, M., Doubova, S. V., Urtasun, M. A., Marín, G. H., Osorio-de-Castro, C. G. S., Albuquerque, F. C., Ribeiro, T. B., Pont, L., Crisóstomo Landeros, J., Roldán Saelzer, J., Sepúlveda Viveros, D., Acosta, A., Machado Beltrán, M. A., Gordillo Alas, L. I., Orellana Tablas, L. A., Benko, R., Convertino, I., Bonaso, M., … Lopes, L. C. (2023). Biosimilars approvals by thirteen regulatory authorities: A cross-national comparison. Regulatory Toxicology and Pharmacology, 144, 105485. https://doi.org/10.1016/j.yrtph.2023.105485
Subjects
biological products

; 

biosimilars

; 

drug approval

; 

adalimumab

; 

alpha2b interferon

; 

beta1b interferon

; 

bevacizumab

; 

biosimilar agent

; 

eculizumab

; 

enoxaparin

; 

etanercept

; 

fenticlor

; 

filgrastim

; 

fiprima

; 

flixceli

; 

human growth hormone

; 

human insulin

; 

infliximab

; 

insulin aspart

; 

insulin glargine

; 

insulin lispro

; 

isophane insulin

; 

novicrit

; 

parathyroid hormone[1-34]

; 

pegfilgrastim

; 

ranibizumab

; 

recombinant erythropoietin

; 

recombinant follitropin

; 

rituximab

; 

trastuzumab

; 

argentina

; 

article

; 

australia

; 

brazil

; 

canada

; 

chile

; 

colombia

; 

drug approval

; 

european medicines agency

; 

food and drug administration

; 

guatemala

; 

hungary

; 

italy

; 

licensing

; 

mexico

; 

peru

; 

practice guideline

; 

united states