相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology
Liqi Xie et al.
BIODRUGS (2020)
Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars
Justin Stebbing et al.
JOURNAL OF CLINICAL ONCOLOGY (2020)
Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
F. Cardoso et al.
ANNALS OF ONCOLOGY (2019)
Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment
Jae Hee Lee et al.
BIODRUGS (2019)
The arrival of biosimilar monoclonal antibodies in oncology: clinical studies for trastuzumab biosimilars
Liese Barbier et al.
BRITISH JOURNAL OF CANCER (2019)
Three-year follow-up from a phase 3 study of SB3 (a trastuzumab biosimilar) versus reference trastuzumab in the neoadjuvant setting for human epidermal growth factor receptor 2-positive breast cancer
Xavier Pivot et al.
EUROPEAN JOURNAL OF CANCER (2019)
Totality of Scientific Evidence in the Development of ABP 980, a Biosimilar to Trastuzumab
Hans-Christian Kolberg et al.
TARGETED ONCOLOGY (2019)
4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)
F. Cardoso et al.
ANNALS OF ONCOLOGY (2018)
AGO Recommendations for the Diagnosis and Treatment of Patients with Early Breast Cancer: Update 2018
Cornelia Liedtke et al.
BREAST CARE (2018)
Can we establish a hierarchy among trastuzumab biosimilar candidates?
Xavier Pivot et al.
BRITISH JOURNAL OF CANCER (2018)
The evolution of biosimilars in oncology, with a focus on trastuzumab
N. A. Nixon et al.
CURRENT ONCOLOGY (2018)
A phase III study comparing SB3 (a proposed trastuzumab biosimilar) and trastuzumab reference product in HER2-positive early breast cancer treated with neoadjuvant-adjuvant treatment: Final safety, immunogenicity and survival results
X. Pivot et al.
EUROPEAN JOURNAL OF CANCER (2018)
American Society of Clinical Oncology Statement: Biosimilars in Oncology
Gary H. Lyman et al.
JOURNAL OF CLINICAL ONCOLOGY (2018)
Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Clinical Practice Guideline Focused Update
Neelima Denduluri et al.
JOURNAL OF CLINICAL ONCOLOGY (2018)
Systemic Therapy for Patients With Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: ASCO Clinical Practice Guideline Update
Sharon H. Giordano et al.
JOURNAL OF CLINICAL ONCOLOGY (2018)
Phase III, Randomized, Double-Blind Study Comparing the Efficacy, Safety, and Immunogenicity of SB3 (Trastuzumab Biosimilar) and Reference Trastuzumab in Patients Treated With Neoadjuvant Therapy for Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer
Xavier Pivot et al.
JOURNAL OF CLINICAL ONCOLOGY (2018)
The LILAC trial and the blooming of anticancer biosimilars
Miguel Martin
LANCET ONCOLOGY (2018)
Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial
Gunter von Minckwitz et al.
LANCET ONCOLOGY (2018)
Rationale, Opportunities, and Reality of Biosimilar Medications
George Y. Tang
NEW ENGLAND JOURNAL OF MEDICINE (2018)
Drifts in ADCC-related quality attributes of Herceptin®: Impact on development of a trastuzumab biosimilar
Seokkyun Kim et al.
MABS (2017)
Biosimilars: Key regulatory considerations and similarity assessment tools
Carol F. Kirchhoff et al.
BIOTECHNOLOGY AND BIOENGINEERING (2017)
Evolving landscape of human epidermal growth factor receptor 2-positive breast cancer treatment and the future of biosimilars
Christian Jackisch et al.
BREAST (2017)
Authorized manufacturing changes for therapeutic monoclonal antibodies (mAbs) in European Public Assessment Report (EPAR) documents
Balazs Vezer et al.
CURRENT MEDICAL RESEARCH AND OPINION (2016)
HannaH phase III randomised study: Association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up
Christian Jackisch et al.
EUROPEAN JOURNAL OF CANCER (2016)
Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers
Josep Tabernero et al.
ESMO OPEN (2016)
Challenges in the implementation of trastuzumab biosimilars: an expert panel's recommendations
Xavier Pivot et al.
ANTI-CANCER DRUGS (2015)
Essential medicines for breast cancer in low and middle income countries
Y. T. Bazargani et al.
BMC CANCER (2015)
Neoadjuvant breast cancer treatment as a sensitive setting for trastuzumab biosimilar development and extrapolation
Christian Jackisch et al.
FUTURE ONCOLOGY (2015)
Drift, Evolution, and Divergence in Biologics and Biosimilars Manufacturing
Sundar Ramanan et al.
BIODRUGS (2014)
Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis
Patricia Cortazar et al.
LANCET (2014)
Barriers to the Use of Trastuzumab for HER2+ Breast Cancer and the Potential Impact of Biosimilars: A Physician Survey in the United States and Emerging Markets
Philip Lammers et al.
PHARMACEUTICALS (2014)
Acceptable changes in quality attributes of glycosylated biopharmaceuticals
Martin Schiestl et al.
NATURE BIOTECHNOLOGY (2011)
Roadmap for implementation of quality by design (QbD) for biotechnology products
Anurag S. Rathore
TRENDS IN BIOTECHNOLOGY (2009)
Drug therapy: Trastuzumab - Mechanism of action and use in clinical practice
Clifford A. Hudis
NEW ENGLAND JOURNAL OF MEDICINE (2007)
Inhibitory Fc receptors modulate in vivo cytoxicity against tumor targets
RA Clynes et al.
NATURE MEDICINE (2000)