SB8: A Bevacizumab Biosimilar.
Journal
Targeted oncology
ISSN: 1776-260X
Titre abrégé: Target Oncol
Pays: France
ID NLM: 101270595
Informations de publication
Date de publication:
12 2020
12 2020
Historique:
pubmed:
19
11
2020
medline:
14
10
2021
entrez:
18
11
2020
Statut:
ppublish
Résumé
SB8 is a biosimilar of the monoclonal anti-VEGF antibody bevacizumab and is approved in the EU for use in the same types of cancer as bevacizumab. SB8 has similar physicochemical and pharmacodynamic properties to those of reference bevacizumab and pharmacokinetic equivalence was shown in healthy volunteers and patients with non-small cell lung cancer (NSCLC). SB8 demonstrated equivalent clinical efficacy to reference bevacizumab in patients with metastatic or recurrent nonsquamous NSCLC, with similar tolerability, safety and immunogenicity profiles.
Identifiants
pubmed: 33206282
doi: 10.1007/s11523-020-00776-0
pii: 10.1007/s11523-020-00776-0
pmc: PMC7733936
doi:
Substances chimiques
Biosimilar Pharmaceuticals
0
Bevacizumab
2S9ZZM9Q9V
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
787-790Commentaires et corrections
Type : ErratumIn
Références
European Medicines Agency. Aybintio 25 mg/ml concentrate for solution for infusion: summary of product characteristics. https://www.ema.europa.eu/ (2020). Accessed 4 Sep 2020.
European Medicines Agency. Aybintio: assessment report. https://www.ema.europa.eu/ (2020). Accessed 4 Sep 2020.
Reck M, Luft A, Bondarenko I, et al. A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer. Lung Cancer. 2020;146:12–8.
doi: 10.1016/j.lungcan.2020.05.027
Shin D, Lee YJ, Choi J, et al. A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers. Cancer Chemother Pharmacol. 2020;86(4):567–75.
doi: 10.1007/s00280-020-04144-7
Park D, Kim J, Yun J, et al. Evaluation of the physico-chemical and biological stability of SB8 (Aybintio), a proposed biosimilar to bevacizumab, under ambient and in-use conditions. Adv Ther. 2020. https://doi.org/10.1007/s12325-020-01465-0 .
doi: 10.1007/s12325-020-01465-0
pubmed: 33179207
pmcid: 7467484
Planchard D, Shin D, Choi J, et al. Exploratory analyses of efficacy from a phase III study comparing SB8, a proposed bevacizumab biosimilar, and reference bevacizumab in patients with metastatic or recurrent non-squamous (NSCLC) [abstract no. 1377P]. Ann Oncol. 2020;31(Suppl. 4):S877–78.
Data on file, Samsung Bioepis (2020).