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Cell-Based Assays to Detect Innate Immune Response Modulating Impurities: Application to Biosimilar Insulin.
AAPS J
December 2024
Laboratory of Immunology, Office of Pharmaceutical Quality Research Division-IV, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, 20993, USA.
Characterizing and mitigating factors that impact product immunogenicity can aid in risk assessment and/or managing risk following manufacturing changes. For follow-on products that have the same indication, patient population, and active product ingredient, the residual immunogenicity risk resides predominantly on differences in product and process related impurities. Characterizing differences in innate immune modulating impurities (IIRMI), which could act as adjuvants by activating local antigen presenting cells (APCs), can inform the immunogenicity risk assessment potentially reducing the need for clinical trials.
View Article and Find Full Text PDFAssessing Functional Similarity of Biosimilar ABP 654 and Ustekinumab in Samples from Patients with Crohn's Disease.
J Inflamm Res
December 2024
Biosimilar Process Development, Amgen Inc., Thousand Oaks, CA, 91320, USA.
Purpose: ABP 654 is the first FDA-approved interchangeable biosimilar for ustekinumab reference product (RP). To support the totality of evidence (TOE), in vitro pharmacology studies were conducted in peripheral blood mononuclear cells (PBMCs) from healthy human donors and Crohn's disease (CD) patients to evaluate IL-23 and IL-12 inhibition by ABP 654 and ustekinumab RP relevant to the mechanism of action of chronic inflammation.
Methods: ABP 654 and ustekinumab RP were assessed using inhibition of IL-23 and IL-12-mediated IFN-γ release, signal transducer and activator of transcription (STAT)3 and STAT4 phosphorylation, and IL-17 release.
Reverse switching from the biosimilar SB2 to the originator infliximab in previously switched patients with inflammatory bowel diseases: results of a prospective long-term cohort study.
Therap Adv Gastroenterol
November 2024
First Department of Medicine, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, Erlangen 91054, Germany.
Background: Data regarding multiple switches including reverse switching between infliximab and its biosimilars are scarce in the field of inflammatory bowel diseases (IBD).
Objectives: We investigated the clinical effectiveness as primary outcome measure after repeated switches. Secondary endpoints included C-reactive protein (CRP) levels, immunogenicity (trough levels (TL); anti-drug antibodies (ADA), safety and drug persistence.
Possibilities and Limitations in Substituting anti-Drug Antibody Titers with Signal-to-Noise Ratios: A Comprehensive Comparison Using Two Clinical Trial Datasets of Adalimumab.
AAPS J
November 2024
Clinical Bioanalysis Group, Samsung Bioepis Co., Ltd, 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea.
Immunogenicity assessment is vital in clinical trials and is measured through a multi-tiered approach (screening, confirmatory and titer assays). However, recent studies have suggested that titer results could be reported from ADA signal-to-noise ratios (S/N ratios=sample mean signal/negative control mean signal). More data analysis using two clinical trials of adalimumab: SB5-1003 (single-dose, healthy participants) and SB5-4001 (multiple-dose, interchangeability study, patients with plaque psoriasis), therefore, is indispensable whether substituting ADA S/N ratio as an alternative way of reporting titer results has no impact on interpretation on clinical outcome.
View Article and Find Full Text PDFImmunogenicity of adalimumab reference product and adalimumab-adbm in patients with rheumatoid arthritis, Crohn's disease and chronic plaque psoriasis: a pooled analysis of the VOLTAIRE trials.
BMJ Open
November 2024
Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
Objective: This post hoc analysis compared the immunogenicity of the biosimilar adalimumab-adbm (Cyltezo) with the adalimumab reference product (RP; Humira) across indications, including rheumatoid arthritis (RA), Crohn's disease (CD) and plaque psoriasis (PsO), and by patient sex in the VOLTAIRE trials programme.
Methods: In each active-comparator randomised controlled trial (RCT), immunogenicity was assessed at various time points by the proportion of patients with antidrug antibodies (ADAs) and neutralising antibodies (nAbs), using acid dissociation followed by electrochemiluminescence assay. Assay sensitivity was 50 ng/mL, and drug tolerance was ≥30 µg/mL (free drug) at the low positive control level.
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