PB006: A Natalizumab Biosimilar.
Journal
Clinical drug investigation
ISSN: 1179-1918
Titre abrégé: Clin Drug Investig
Pays: New Zealand
ID NLM: 9504817
Informations de publication
Date de publication:
29 Apr 2024
29 Apr 2024
Historique:
accepted:
01
04
2024
medline:
29
4
2024
pubmed:
29
4
2024
entrez:
29
4
2024
Statut:
aheadofprint
Résumé
PB006 (Tyruko
Identifiants
pubmed: 38683493
doi: 10.1007/s40261-024-01360-4
pii: 10.1007/s40261-024-01360-4
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
European Medicines Agency. Tyruko: EU summary of product characteristics. 2023. https://www.ema.europa.eu . Accessed 02 Apr 2024.
European Medicines Agency. Tyruko: European public assessment report. 2023. https://www.ema.europa.eu . Accessed 02 Apr 2024.
Wessels H, von Richter O, Velinova M, et al. Pharmacokinetic and pharmacodynamic similarity of biosimilar natalizumab (PB006) to its reference medicine: a randomized controlled trial. Expert Opin Biol Ther. 2023;23(12):1287–97.
doi: 10.1080/14712598.2023.2290530
pubmed: 38044885
Hemmer B, Wiendl H, Roth K, et al. Efficacy and safety of proposed biosimilar natalizumab (PB006) in patients with relapsing-remitting multiple sclerosis: the Antelope phase 3 randomized clinical trial. JAMA Neurol. 2023;80(3):298–307.
doi: 10.1001/jamaneurol.2022.5007
pubmed: 36689214
pmcid: 9871944
Plavina T, Subramanyam M, Bloomgren G, et al. Anti-JC virus antibody levels in serum or plasma further define risk of natalizumab-associated progressive multifocal leukoencephalopathy. Ann Neurol. 2014;76(6):802–12.
doi: 10.1002/ana.24286
pubmed: 25273271