Cargando…

Pharmacokinetic Bioequivalence, Safety, and Immunogenicity of DMB-3111, a Trastuzumab Biosimilar, and Trastuzumab in Healthy Japanese Adult Males: Results of a Randomized Trial

BACKGROUND: DMB-3111 is a biosimilar trastuzumab drug being jointly developed by Meiji Seika Pharma (Japan) and Dong-A Socio Holdings (Korea). We investigated the bioequivalence of DMB-3111 relative to trastuzumab. OBJECTIVES: The aim of this study was to investigate the bioequivalence between DMB-3...

Descripción completa

Detalles Bibliográficos
Autores principales:	Morita, Jun, Tanaka, Masashi, Nomoto, Masahiro, Matsuki, Shunji, Tsuru, Tomomi, Matsuguma, Kyoko, Shiramoto, Masanari
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2015
Materias:	Original Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4746214/ https://www.ncbi.nlm.nih.gov/pubmed/26691837 http://dx.doi.org/10.1007/s40259-015-0153-2

Ejemplares similares

Intravenous and subcutaneous formulations of trastuzumab, and trastuzumab biosimilars: implications for clinical practice
por: Waller, Cornelius F., et al.
Publicado: (2021)

Concepts and Challenges of Biosimilars in Breast Cancer: The Emergence of Trastuzumab Biosimilars
por: Uifălean, Alina, et al.
Publicado: (2018)

Population pharmacokinetics of PF-05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin(®)) in patients with HER2-positive metastatic breast cancer
por: Chen, Xiaoying, et al.
Publicado: (2019)

Physicochemical and Biological Characterization of a Biosimilar Trastuzumab
por: López-Morales, Carlos A., et al.
Publicado: (2015)

The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars
por: Barbier, Liese, et al.
Publicado: (2019)

Pharmacokinetic Comparability of a Biosimilar Trastuzumab Anticipated from Its Physicochemical and Biological Characterization
por: Miranda-Hernández, Mariana P., et al.
Publicado: (2015)

Correction to: Population pharmacokinetics of PF‑05280014 (a trastuzumab biosimilar) and reference trastuzumab (Herceptin(®)) in patients with HER2‑positive metastatic breast cancer
por: Chen, Xiaoying, et al.
Publicado: (2019)

Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer
por: Lammers, Philip E., et al.
Publicado: (2018)

Functional and Nonclinical Similarity of ABP 980, a Biosimilar of Trastuzumab
por: Jassem, Shea, et al.
Publicado: (2019)

Cost effectiveness of using trastuzumab biosimilars compared to trastuzumab original drugs to treat breast cancer in a hospital setting
por: Barat, Eric C., et al.
Publicado: (2023)

Safety survey on infusion reaction and cardiac dysfunction when switching from reference trastuzumab (HERCEPTIN(®)) to biosimilar trastuzumab (Trastuzumab‑NK) in the treatment of HER2‑positive breast cancer
por: Abe, Tomoya, et al.
Publicado: (2023)

Comparative Nonclinical Assessments of the Proposed Biosimilar PF-05280014 and Trastuzumab (Herceptin(®))
por: Hurst, Susan, et al.
Publicado: (2014)

Can we establish a hierarchy among trastuzumab biosimilar candidates?
por: Pivot, Xavier, et al.
Publicado: (2018)

Assessment of the Molecular Mechanism of Action of SB3, a Trastuzumab Biosimilar
por: Paek, Kyungyeol, et al.
Publicado: (2019)

Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab
por: Kolberg, Hans-Christian, et al.
Publicado: (2019)

Systematic Review on the Use of Biosimilars of Trastuzumab in HER2+ Breast Cancer
por: Triantafyllidi, Eleni, et al.
Publicado: (2022)

A Review of Trastuzumab Biosimilars in Early Breast Cancer and Real World Outcomes of Neoadjuvant MYL-1401O versus Reference Trastuzumab
por: Yang, Charlie, et al.
Publicado: (2022)

Trastuzumab immunogenicity development in patients’ sera and in laboratory animals
por: Kilany, Lobna Abdel Aziz, et al.
Publicado: (2021)

In-depth structural characterization of Kadcyla® (ado-trastuzumab emtansine) and its biosimilar candidate
por: Chen, Liuxi, et al.
Publicado: (2016)

Assessing Analytical and Functional Similarity of Proposed Amgen Biosimilar ABP 980 to Trastuzumab
por: Hutterer, Katariina M., et al.
Publicado: (2019)

Simulating Costs of Intravenous Biosimilar Trastuzumab vs. Subcutaneous Reference Trastuzumab in Adjuvant HER2-Positive Breast Cancer: A Belgian Case Study
por: Simoens, Steven, et al.
Publicado: (2021)

Focus on biosimilar etanercept – bioequivalence and interchangeability
por: Cantini, Fabrizio, et al.
Publicado: (2018)

Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar
por: Kim, Seokkyun, et al.
Publicado: (2017)

Dermatomyositis following Biosimilar Trastuzumab in a Breast Cancer Patient: A Case Report
por: Moghimi, Minoosh, et al.
Publicado: (2021)

Totality of Evidence Supporting the Use of ABP 980, a Trastuzumab Biosimilar: Practical Considerations
por: Kolberg, Hans-Christian, et al.
Publicado: (2021)

Budget Impact Analysis of the Introduction of Rituximab and Trastuzumab Intravenous Biosimilars to EU-5 Markets
por: Jang, Minyoung, et al.
Publicado: (2020)

The Impact of Introducing Successive Biosimilars on Changes in Prices of Adalimumab, Infliximab, and Trastuzumab—Polish Experiences
por: Barszczewska, Olga, et al.
Publicado: (2021)

Efficacy and Safety of Trastuzumab Biosimilar (CT-P6) Compared With Reference Trastuzumab in Patients With HER2-positive Advanced Gastric Cancer: A Retrospective Analysis
por: Park, Joo-Hwan, et al.
Publicado: (2022)

Similar Pharmacokinetics and Pharmacodynamics of Biosimilar SAR342434 Insulin Lispro and Japan‐Approved Humalog Insulin Lispro in Healthy Japanese Subjects
por: Shiramoto, Masanari, et al.
Publicado: (2022)

Resistance to Trastuzumab
por: Vivekanandhan, Sneha, et al.
Publicado: (2022)

Comparison of Biosimilar Trastuzumab ABP 980 with Reference Trastuzumab in Neoadjuvant Therapy for HER2-positive Breast Cancer – an Analysis of a Large University Breast Cancer Centre
por: Matovina, Sabine, et al.
Publicado: (2022)

In silico design, construction and cloning of Trastuzumab humanized monoclonal antibody: A possible biosimilar for Herceptin
por: Akbarzadeh-Sharbaf, Soudabeh, et al.
Publicado: (2012)

Extended Stability of Reconstituted and Diluted SB3 (Trastuzumab Biosimilar) Assessed by Physicochemical and Biological Properties
por: Yun, Jihoon, et al.
Publicado: (2019)

Screening and selection strategy for the establishment of biosimilar to trastuzumab-expressing CHO-K1 cell lines
por: Lao-Gonzalez, Thailin, et al.
Publicado: (2021)

Trastuzumab-induced thrombocytopenia after eight cycles of trastuzumab treatment
por: Zhou, Qiong, et al.
Publicado: (2020)

Update on the safety and bioequivalence of biosimilars – focus on enoxaparin
por: Jeske, Walter, et al.
Publicado: (2013)

Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab
por: Pimentel, Franklin Fernandes, et al.
Publicado: (2018)

A randomized, single-blind, single-dose study evaluating the pharmacokinetic equivalence of proposed biosimilar ABP 980 and trastuzumab in healthy male subjects
por: Hanes, Vladimir, et al.
Publicado: (2017)

Trastuzumab Charge Variants: a Study on Physicochemical and Pharmacokinetic Properties
por: Torkashvand, Fatemeh, et al.
Publicado: (2023)

Uptake of biosimilar trastuzumab in Denmark compared with other European countries: a comparative study and discussion of factors influencing implementation and uptake of biosimilars
por: Azuz, Samuel, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_h44l1bn2ct08a8e5857t8ias31