A Systematic Review on Infliximab Biosimilar SB2: From Pre-Clinical Data to Real-World Evidence

Abstract

Introduction:The infliximab biosimilar SB2 was approved in the EU (2016, Flixabi ® ) and the US (2017, Renflexis ® ) for the same indications as the reference product (Remicade ® ) based on a robust analytical and clinical data package.Areas covered: This systematic literature review summarizes available analytical and clinical data on SB2, including randomized controlled clinical trials and real-world evidence studies. Overall, 184 articles and congress abstracts were identified (excluding duplicates), whereof 5 reports on analytical data, four reports on two randomized controlled trials and 13 reports of real-world evidence studies were included. Expert opinion:The available analytical and clinical data support the equivalence of SB2 to the reference product across approved indications. This is further supported by emerging real-world evidence, particularly in extrapolated indications such as inflammatory bowel disease for both infliximab-naïve patients and patients already established on infliximab switching to SB2. Switching from originator or biosimilar infliximab to SB2 including both single and multiple switches was not associated with an increased risk of loss of treatment response or any safety or immunogenicity concerns. Overall, the approved infliximab biosimilar SB2 is safe and effective in clinical practice across licensed indications.

Pathogenetic mechanism and therapeutic target for inflammation in autoimmune disease

“…As with VCAM-1, conflicting results have also been reported for serum ICAM-1 and E-selectin levels in SLE and LN patients and their association with clinical and serological parameters of disease (52,152,162,(164)(165)(166)(167)(168)(169)(170)(171). The discrepancies may be related to differences in the characteristics of patients, ethnicity and management, the timing of sample collection in relation to disease activity, and differences in the sensitivity of assays used (52,134,172).…”

The role of inflammation in autoimmune disease: a therapeutic target

“…SB-2 differs from Infliximab in that the murine cells used (a Chinese hamster ovary (CHO) cell line) are different, which may lead to differences in C-terminal Lys residues, changing the proportion of their different charge isomers, but this does not affect the site recognition and antigen fragment binding of SB-2, which has a high degree of biological similarity with IFX. SB-2 is currently approved by the European Union in 2015 for the treatment of IFX indications ( 163 , 166 ). PF-06438179 (GP1111) is another IFX biosimilar produced after SB-2, developed in accordance with regulatory recommendations from the FDA and EMA.…”

A review of the therapeutic management of ulcerative colitis

“…Furthermore, CT-P13 is also available in a subcutaneous (SC) preparation, offering more options to patients with UC. Numerous studies based upon real-world experience have been described, with two recent systematic reviews for CT-P13 66 and SB2 67 having shown comparable effectiveness in clinical and endoscopic outcomes, with consideration for multiple switches and therapeutic drug monitoring taken into consideration.…”