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Open Access 01-12-2020 | NSCLC | Adis Biosimilar Brief

SB8: A Bevacizumab Biosimilar

Author: Yahiya Y. Syed

Published in: Targeted Oncology | Issue 6/2020

Abstract

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.

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.CrossRef

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.CrossRef

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.CrossRefPubMedPubMedCentral

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).

Title: SB8: A Bevacizumab Biosimilar
Author: Yahiya Y. Syed
Publication date: 01-12-2020
Publisher: Springer International Publishing
Keywords: NSCLC
NSCLC
Bevacizumab
Published in: Targeted Oncology / Issue 6/2020
Print ISSN: 1776-2596
Electronic ISSN: 1776-260X
DOI: https://doi.org/10.1007/s11523-020-00776-0

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