Abstract
PurposeABP 710 has been developed as a biosimilar to infliximab reference product (RP). The objective of this study was to assess analytical similarity (structural and functional) between ABP 710 and infliximab RP licensed by the United States Food and Drug Administration (infliximab [US]) and the European Union (infliximab [EU]), using sensitive, state-of-the-art analytical methods capable of detecting minor differences in product quality attributes.MethodsComprehensive analytical characterization utilizing orthogonal techniques was performed with 14 to 28 unique lots of ABP 710 or infliximab RP, depending on the assay. Comparisons were used to investigate the primary structure related to amino acid sequence; post-translational modifications (PTMs) including glycans; higher order structure; particles and aggregates; primary biological properties mediated by target and receptor binding; product-related substances and impurities; and general properties.ResultsABP 710 had the same amino acid sequence, primary structure, higher order structure, PTM profiles and biological activities as infliximab RP. The finished drug product had the same strength (protein content and concentration) as infliximab RP.ConclusionsBased on the comprehensive analytical similarity assessment, ABP 710 was found to be highly analytically similar to infliximab RP for all biological activities relevant for clinical efficacy and safety.
Highlights
ABP 710 has been developed as a biosimilar to infliximab reference product (RP) (Remicade®)
The ABP 710 batches used in the similarity assessment represent drug product lots filled from 14 individual drug substance lots manufactured over the same period
For parameters primarily influenced by the drug product manufacturing process, 19 drug product lots were included in the analytical similarity assessment, including all lots used in clinical studies and drug product process validation lots
Summary
ABP 710 has been developed as a biosimilar to infliximab reference product (RP) (Remicade®). The primary mechanism of action of infliximab RP is to neutralize the biological activity of tumor necrosis factoralpha (TNFα) by binding with high affinity to the soluble TNFα (sTNFα) and membrane bound (mb) forms of TNFα (mbTNFα) and inhibit binding of TNFα with its receptors [2,3]. The antigen binding fragment (Fab) of infliximab RP mediates the binding to TNFα and its subsequent neutralization; it can induce apoptosis through reverse signaling in mbTNFα expressing cells. Infliximab RP can induce antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) of mbTNFα-expressing cells through the Fccontaining portion of the molecule [4]
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