The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars

L Barbier, P Declerck, S Simoens, P Neven… - British journal of …, 2019 - nature.com
The monoclonal antibody trastuzumab (Herceptin®), which targets the human epidermal
growth factor receptor 2 (HER2), is approved for the treatment of early breast and advanced …

[HTML][HTML] The global need for a trastuzumab biosimilar for patients with HER2-positive breast cancer

K Blackwell, J Gligorov, I Jacobs, C Twelves - Clinical breast cancer, 2018 - Elsevier
Trastuzumab improves survival outcomes for patients with HER2-positive (HER2+) breast
cancer, yet not all such women receive this important therapy. Trastuzumab was approved …

Drifts in ADCC-related quality attributes of Herceptin®: impact on development of a trastuzumab biosimilar

S Kim, J Song, S Park, S Ham, K Paek, M Kang… - MAbs, 2017 - Taylor & Francis
ABSTRACT A biosimilar product needs to demonstrate biosimilarity to the originator
reference product, and the quality profile of the latter should be monitored throughout the …

Phase III, randomized, double-blind study comparing the efficacy, safety, and immunogenicity of SB3 (trastuzumab biosimilar) and reference trastuzumab in patients …

X Pivot, I Bondarenko, Z Nowecki, M Dvorkin… - Journal of Clinical …, 2018 - ascopubs.org
Purpose This phase III study compared SB3, a trastuzumab (TRZ) biosimilar, with reference
TRZ in patients with human epidermal growth factor receptor 2–positive early breast cancer …

[HTML][HTML] A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with …

X Pivot, I Bondarenko, Z Nowecki, M Dvorkin… - European Journal of …, 2018 - Elsevier
Background The equivalent efficacy between SB3, a proposed trastuzumab biosimilar, and
the trastuzumab reference product (TRZ) in terms of the breast pathologic complete …

Safety and efficacy of biosimilars in oncology

H Schellekens, JS Smolen, M Dicato… - The Lancet …, 2016 - thelancet.com
Biosimilars are considered to be one of the solutions to combat the substantially increasing
costs of cancer treatment, and its imminent introduction is expected to expand affordability …

Understanding the role of comparative clinical studies in the development of oncology biosimilars

J Stebbing, PN Mainwaring, G Curigliano… - Journal of Clinical …, 2020 - ascopubs.org
Biosimilars have the potential to broaden patient access to biologics and provide cost
savings for health care systems. During the development of a biosimilar, data that directly …

Biosimilars for breast cancer: a review of HER2-targeted antibodies in the United States

EM Miller, LS Schwartzberg - Therapeutic Advances in …, 2019 - journals.sagepub.com
The utilization of trastuzumab biosimilar medications is of particular interest in HER2-
positive breast cancer as these drugs have the potential for cost savings and increased …

A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN-and EU-sourced trastuzumab in healthy subjects

X Zhu, Y Ding, Y Yu, M Wang, W Zhou, J Wang… - Cancer Chemotherapy …, 2021 - Springer
Purpose This study evaluated the bioequivalence of China-manufactured biosimilar, HLX02,
to reference China (CN)-and European Union (EU)-sourced trastuzumab. Methods This was …

Biologic drug quality assurance to optimize HER2+ breast cancer treatment: insights from development of the trastuzumab biosimilar SB3

D Lüftner, GH Lyman, J Gonçalves, X Pivot, M Seo - Targeted oncology, 2020 - Springer
SB3 is a biosimilar of trastuzumab that has been approved for use in the treatment of human
epidermal growth factor 2-positive breast cancer and human epidermal growth factor 2 …