ifx-bs infliximab biosimilar 3  (Pfizer Inc)

Journal: Frontiers in Immunology

Article Title: The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring

doi: 10.3389/fimmu.2025.1550655

Figure Lengend Snippet: Characteristics of the antibodies sourced for the infliximab ADA reference panel.

Article Snippet: Loss of patent exclusivity, however led to the European approval of the first biosimilar IFX (Remsima ® /Inflectra ® , Celltrion Inc/Hospira in 2013) followed by other biosimilars worldwide which is contributing to a decrease in drug costs, in widening patient access and is significantly transforming disease management across different indications.

Techniques: Activity Assay, Binding Assay

Journal: Frontiers in Immunology

Article Title: The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring

doi: 10.3389/fimmu.2025.1550655

Figure Lengend Snippet: Characteristics of lyophilized infliximab ADA preparations.

Article Snippet: Loss of patent exclusivity, however led to the European approval of the first biosimilar IFX (Remsima ® /Inflectra ® , Celltrion Inc/Hospira in 2013) followed by other biosimilars worldwide which is contributing to a decrease in drug costs, in widening patient access and is significantly transforming disease management across different indications.

Techniques:

Journal: Frontiers in Immunology

Article Title: The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring

doi: 10.3389/fimmu.2025.1550655

Figure Lengend Snippet: (A) Binding profile of the anti-infliximab mAbs, A and B (bulk material) and the liquid mAbs (N-S) as demonstrated by SPR. (B) Sensorgram generated from a representative single cycle kinetic experiment in which the anti-infliximab mAbs A and B (bulk material) and the liquid mAbs were comparatively assessed for affinity ranking (Top). The profile of the mAbs A, B (both bulk material) and mAb N (mixture of A and B) is also illustrated separately (Bottom).

Article Snippet: Loss of patent exclusivity, however led to the European approval of the first biosimilar IFX (Remsima ® /Inflectra ® , Celltrion Inc/Hospira in 2013) followed by other biosimilars worldwide which is contributing to a decrease in drug costs, in widening patient access and is significantly transforming disease management across different indications.

Techniques: Binding Assay, Generated

Journal: Frontiers in Immunology

Article Title: The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring

doi: 10.3389/fimmu.2025.1550655

Figure Lengend Snippet: Data from a representative ELISA assay illustrating the binding profiles of the different infliximab ADAs (Top Panel). The hatched lines represent the cut-off level (average +1.645 StDev NC). Data from a cell-based bioassay showing the neutralizing profiles of the infliximab ADAs (Bottom Panel). The hatched lines represent the levels of SEAP detected with the assay controls (cells only, cell and infliximab, cells and TNF).

Article Snippet: Loss of patent exclusivity, however led to the European approval of the first biosimilar IFX (Remsima ® /Inflectra ® , Celltrion Inc/Hospira in 2013) followed by other biosimilars worldwide which is contributing to a decrease in drug costs, in widening patient access and is significantly transforming disease management across different indications.

Techniques: Enzyme-linked Immunosorbent Assay, Binding Assay, Bioassay

Journal: Frontiers in Immunology

Article Title: The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring

doi: 10.3389/fimmu.2025.1550655

Figure Lengend Snippet: Detection of anti-infliximab mAbs A (INA 29) and B (INA 79) in a bridging ELISA using Remicade (red), Flixabi (green) or Remsima (blue).

Article Snippet: Loss of patent exclusivity, however led to the European approval of the first biosimilar IFX (Remsima ® /Inflectra ® , Celltrion Inc/Hospira in 2013) followed by other biosimilars worldwide which is contributing to a decrease in drug costs, in widening patient access and is significantly transforming disease management across different indications.

Techniques: Enzyme-linked Immunosorbent Assay

Journal: Life Science Alliance

Article Title: Assessing MAPPs assay as a tool to predict the immunogenicity potential of protein therapeutics

doi: 10.26508/lsa.202302095

Figure Lengend Snippet: Three donors (BC01, BC02, and BC03) were tested in triplicate (independent samples) to assess assay intra-day/intra-donor reproducibility, infliximab (IFX) concentration 10 μg/ml. (A) IFX heavy chain peptides (light orange); IFX light chain peptides (dark green). Complementarity-determining regions are shown in different colors according to the legend in the picture. (B) Venn plots for reproducibility assessment of technical replicates for peptide sequences. More details are in SI ( , , and ).

Article Snippet: Model therapeutic antibodies were IFX biosimilar (SIM0006; BioXcell), Bs-mAb1 and Bs-mAb2 were internally produced at Merck KGaA, trastuzumab IgG1 was made at Merck KGaA.

Techniques: Concentration Assay

Journal: Life Science Alliance

Article Title: Assessing MAPPs assay as a tool to predict the immunogenicity potential of protein therapeutics

doi: 10.26508/lsa.202302095

Figure Lengend Snippet: (A) Box plot of log 2 summed peptide abundances (named as protein abundance in the plot) comparison between FG-NHS (blue) and streptavidin beads (orange), on three different donors. (B) MHC-II-associated peptide proteomics heatmap showing the MHC-II eluted ligands from infliximab (IFX)-treated DCs. Only BC115 (responding to HC-IFX) peptides were shown, instead BC65 and BC125 did not show any IFX peptides. (C, D, E) Volcano plots of MHC-II ligand ratio abundance (streptavidin to FG-NHS ratio) for BC115, 65, and 125, respectively. Threshold: log 2 ratio = ±1.0, −log 10 P value = 1.3. For details about peptide quantification, please see .

Article Snippet: Model therapeutic antibodies were IFX biosimilar (SIM0006; BioXcell), Bs-mAb1 and Bs-mAb2 were internally produced at Merck KGaA, trastuzumab IgG1 was made at Merck KGaA.

Techniques: Quantitative Proteomics, Comparison

Journal: Life Science Alliance

Article Title: Assessing MAPPs assay as a tool to predict the immunogenicity potential of protein therapeutics

doi: 10.26508/lsa.202302095

Figure Lengend Snippet: MAPPs MHC-II peptides of five different HLA-genotyped donors. (A) MAPPs MHC-II peptides of infliximab HC and LC. (B, C) MAPPs MHC-II peptides of Bet v1a and KLH, respectively. (D) Donor clustering based on MHC-II ligandome (red: increased peptide expression; green: decreased peptide expression; black: same peptide expression; white: missing peptide, Euclidian distance was used for hierarchical clustering). Negative control (Ctrl neg) samples (untreated cells from the same donor) were also included in the MAPPs study.

Article Snippet: Model therapeutic antibodies were IFX biosimilar (SIM0006; BioXcell), Bs-mAb1 and Bs-mAb2 were internally produced at Merck KGaA, trastuzumab IgG1 was made at Merck KGaA.

Techniques: Expressing, Negative Control

Journal: Life Science Alliance

Article Title: Assessing MAPPs assay as a tool to predict the immunogenicity potential of protein therapeutics

doi: 10.26508/lsa.202302095

Figure Lengend Snippet: (A) Box plot showing a normal distribution for the whole MHC-II-associated peptide proteomics MHC-II-eluted ligands. (B, C, D) Violin plots showing the distribution of the data for the different identified peptide lengths in the same five HLA-genotyped donors for (B) infliximab (yellow), (C) KLH (red), and (D) Bet v1a (blue). The median is represented by a white dot in the violin plot. The interquartile range (IQR) is the black bar in the center of violin. The lower/upper adjacent values (the black lines stretched from the bar that overlap with the two ends of Kernel density distribution) are defined as first quartile- 1.5 IQR and third quartile + 1.5 IQR respectively. Peptide lengths were arranged to an ascending order of median percentage frequency for each individual tested protein.

Article Snippet: Model therapeutic antibodies were IFX biosimilar (SIM0006; BioXcell), Bs-mAb1 and Bs-mAb2 were internally produced at Merck KGaA, trastuzumab IgG1 was made at Merck KGaA.

Techniques: