ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2019
Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Clinical Similarity of Biosimilars and Reference Drugs: A Comprehensive Review and New Hope for Public Health in a New Frontier.Current drug research reviews · 2025Pooled it
- Biosimilars: A Virtuous Cycle of Sustainability and Innovation.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Review of Quality Attributes and Analytical Methods Used for Comparative Analytical Assessment of Monoclonal Antibodies as Part of Successful Biosimilar Approvals in the United States and European Union.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026Review
- Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025Article
- The devolution of biosimilars regulations.Nature biotechnology · 2025Article
- Basic regulatory science behind drug substance and drug product specifications of monoclonal antibodies and other protein therapeutics.Journal of pharmaceutical analysis · 2024Review
- Drifts in N-Linked Glycosylation Result in ADCC Potency Variation of Perjeta® from August 2020 to October 2021 in China.BioMed research international · 2022Article
- Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Article
- New Quality-Range-Setting Method Based on Between- and Within-Batch Variability for Biosimilarity Assessment.Pharmaceuticals (Basel, Switzerland) · 2021Article
- Maintaining 'standards' for biosimilar monoclonal antibodies.Nature biotechnology · 2021Article
- Biologic Drug Quality Assurance to Optimize HER2 + Breast Cancer Treatment: Insights from Development of the Trastuzumab Biosimilar SB3.Targeted oncology · 2020Review
- Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to HerceptinBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Article
- The Path Towards a Tailored Clinical Biosimilar Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Batch-to-Batch Consistency of SB4 and SB2, Etanercept and Infliximab Biosimilars.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Article
- Assessment of the Molecular Mechanism of Action of SB3, a Trastuzumab Biosimilar.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSB3 has been developed as a trastuzumab biosimilar, a therapeutic monoclonal antibody targeted to human epidermal growth factor receptor 2 (HER2), and approved by the European Commission and United States (US) Food and Drug Administration (FDA). During the developmental period of a biosimilar, setting an appropriate quality target is critical for assessing the similarity of the biosimilar product to the reference product. A stepwise approach should be taken to assessing similarity, beginning with extensive characterization of the reference product to establish the quality target.
objectiveIn this study, we evaluated the similarity of SB3 to the reference product and the impact of changes in the biological profile of the reference product on similarity assessment.
methodsAnalytical similarity was assessed with defined test procedures in terms of critical quality attributes (CQAs) that could affect efficacy, potency, and safety, as well as for the non-CQAs that are related to process consistency. The quality target was established using up to 154 lots of European Union (EU)- and US-sourced Herceptin
resultsTrends of the EU- and US-sourced reference product showed that the biological profile exhibited two marked changes for Fc-related attributes, and then recovered to pre-change quality level. Since the similarity range set by pre-change lots was considered most relevant, the changed lots were excluded from establishing the similarity range, which resulted in tightened acceptance criteria. As shown in the results of similarity assessment using the stringent quality target ranges, SB3 exhibits highly similar functional activities compared to the reference product in terms of both CQAs and non-CQAs.
conclusionSB3 has been developed as a trastuzumab biosimilar approved in the EU and USA, and its manufacturing process is deemed to be robust and well-controlled within stringent quality target ranges.
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