AIMC Topic: Biosimilar Pharmaceuticals

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Multiple switching between the biosimilar adalimumab PF-06410293 and reference adalimumab in patients with active rheumatoid arthritis: a phase 3, open-label, randomised, parallel-group study.

The Lancet. Rheumatology Aug 21, 2023
BACKGROUND: An adalimumab biosimilar with an interchangeability designation could increase access to effective treatment for more patients. We aimed to assess the interchangeability of adalimumab biosimilar PF-06410293 (adalimumab-afzb) and reference...
Humans Female Male Middle Aged Arthritis, Rheumatoid Methotrexate Adalimumab Biosimilar Pharmaceuticals
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Stability of infliximab solutions in different temperature and dilution conditions.

Journal of pharmaceutical and biomedical analysis Dec 18, 2017
Infliximab is a monoclonal antibody widely used for the treatment of inflammatory diseases. Over the past few years, many studies have assessed that monoclonal antibodies are prone to aggregation under stress conditions. The aim of this study was to ...
Temperature Time Factors Nanoparticles Spectroscopy, Fourier Transform Infrared Infliximab Biosimilar Pharmaceuticals Protein Stability Drug Stability Drug Compounding Osmolar Concentration Pharmaceutical Solutions Technology, Pharmaceutical Antirheumatic Agents Protein Aggregates Spectrophotometry, Ultraviolet Chromatography, Gel Chromatography, Ion Exchange Nephelometry and Turbidimetry Peptide Mapping
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Biosimilarity Assessments of Model IgG1-Fc Glycoforms Using a Machine Learning Approach.

Journal of pharmaceutical sciences Dec 30, 2015
Biosimilarity assessments are performed to decide whether 2 preparations of complex biomolecules can be considered "highly similar." In this work, a machine learning approach is demonstrated as a mathematical tool for such assessments using a variety...
Machine Learning Immunoglobulin G Biosimilar Pharmaceuticals Protein Stability Immunoglobulin Fc Fragments
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A comparative phase III clinical study to evaluate efficacy and safety of TrastuRel™ (biosimilar trastuzumab) and innovator trastuzumab in patients with metastatic human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.

Indian journal of cancer Jan 1, 2017
INTRODUCTION: The present study for biosimilar trastuzumab was a multicentric, randomized, two-arm parallel-group, comparative phase III study in patients with metastatic breast cancer.
Humans Female Aged Adult Breast Neoplasms Middle Aged India Antineoplastic Combined Chemotherapy Protocols Remission Induction Biosimilar Pharmaceuticals Drug-Related Side Effects and Adverse Reactions Paclitaxel Disease-Free Survival Receptor, ErbB-2 Trastuzumab
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