SB8: A Bevacizumab Biosimilar

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.

Evaluate the value of prolonging the duration of tiopronin for injection administration in preventing hepatotoxicity

“…Thus, instead of using the criteria for drug hepatotoxicity, we used the criteria for hepatotoxicity established by the World Health Organization. Hepatotoxicity was not reported among the adverse reactions of bevacizumab 27 , 28 , therefore, bevacizumab is not necessary for grouping chemotherapy drugs. CTLA-4 and PD-1 immune checkpoint inhibitors can cause immune-related hepatotoxicity 24 , 25 , however, the mechanism of immune-related hepatotoxicity is different from that of chemotherapeutic drugs, so immune checkpoint inhibitors are included in other chemotherapeutic drug groups.…”

Recent advances in structural mass spectrometry methods in the context of biosimilarity assessment: from sequence heterogeneities to higher order structures

“…In 2000, the concept of "generic" mAb was introduced and termed biosimilars, as copy versions of originator mAb products produced worldwide [6][7][8][9]. The first two infliximab (anti-TNFα) biosimilar products were approved by the European Medicines Agency (EMA) in 2013 [10,11], followed a few years later by biosimilar versions of adalimumab (anti-TNFα), rituximab (anti-CD20), bevacizumab (anti-VEGF) or trastuzumab (anti-HER2) [12][13][14]. Currently, 249 mAb biosimilars for 12 reference products have been approved [1].…”