SB8: A Bevacizumab Biosimilar
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ADIS BIOSIMILAR BRIEF
SB8: A Bevacizumab Biosimilar Yahiya Y. Syed1 Published online: 18 November 2020 © Springer Nature Switzerland AG 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.
Key Points Biosimilar to bevacizumab Equivalent efficacy and similar tolerability to reference bevacizumab in patients with metastatic or recurrent nonsquamous NSCLC Approved for same types of cancer for which bevacizumab is approved
the EU for same types of cancer as bevacizumab (Table 2) [1]. SB8 has similar physicochemical, functional and pharmacodynamic characteristics to those of reference bevacizumab [2, 3] and pharmacokinetic similarity of the agents has also been demonstrated [3, 4]. This article summarizes, from an EU perspective, the key features of SB8 and its clinical use in the treatment of various cancers, focusing on non-small cell lung cancer (NSCLC).
2 Clinical Pharmacology 1 Introduction SB8 is a biosimilar of the monoclonal anti-vascular endothelial growth factor (VEGF) antibody bevacizumab. The product details are summarized in Table 1. SB8 is approved in Enhanced material for this Adis Biosimilar Brief can be found at https://doi.org/10.6084/m9.figshare.13175600. The manuscript was reviewed by: K. Araki, Department of Medical Oncology, Gunma Prefectural Cancer Center, Gunma, Japan; P. Gascon, Laboratory of Molecular and Translational Oncology, CELLEX, Barcelona, Spain, S. Gathers, Community Response, Medical University of South Carolina Charleston, Charleston, SC, USA. * Yahiya Y. Syed [email protected] 1
Springer Nature, Private Bag 65901, Mairangi Bay, Auckland 0754, New Zealand
SB8 has similar physiochemical characteristics and functional properties to those of reference bevacizumab (Table 3) [2, 3]. In vitro functional assay data are supported by comparable anti-tumour activity of SB8 and reference bevacizumab in a human NSCLC xenograft mice model [2]. Pharmacokinetic similarity of SB8 to EU-sourced bevacizumab was demonstrated in a randomized, double-blind, phase 1 pharmacokinetic study in healthy volunteers [4]. The 90% CI for geometric least squares means ratios for the primary endpoints of area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration and the maximum observed serum concentrations (Cmax) were within the prespecified bioequivalence margin of 80.00–125.00% [4]. Furthermore, in a phase 3 study in patients with NSCLC (Sect. 3), Cmax and trough serum concentrations at cycles 1, 3, 5 and 7 were large
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