Demonstrating Analytical Similarity of Trastuzumab Biosimilar HLX02 to Herceptin® with a Panel of Sensitive and Orthogonal Methods Including a Novel FcγRIIIa Affinity Chromatography Technology

Physicochemical and functional assessments demonstrating analytical similarity between rituximab biosimilar HLX01 and the MabThera®

(2019) Yanpeng Xu et al.   mAbs

Evaluation of survival by ADCC status: Subgroup analysis of SB3 (Trastuzumab Biosimilar) and reference trastuzumab in patients with HER2-positive early breast cancer at three-year follow-up.

(2019) Xavier Pivot et al.   JOURNAL OF CLINICAL ONCOLOGY

Biological Characterization of SB3, a Trastuzumab Biosimilar, and the Influence of Changes in Reference Product Characteristics on the Similarity Assessment

(2019) Jae Hee Lee et al.   BIODRUGS

The Global Need for a Trastuzumab Biosimilar for Patients With HER2-Positive Breast Cancer

(2018) Kimberly Blackwell et al.   Clinical Breast Cancer

Assessing the Heterogeneity of the Fc-Glycan of a Therapeutic Antibody Using an engineered FcγReceptor IIIa-Immobilized Column

(2018) Masato Kiyoshi et al.   Scientific Reports

Influence of N-glycosylation on effector functions and thermal stability of glycoengineered IgG1 monoclonal antibody with homogeneous glycoforms

(2018) Ryuta Wada et al.   mAbs

11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial

(2017) David Cameron et al.   LANCET

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

(2017) Seokkyun Kim et al.   mAbs

CD55 and CD59 expression protects HER2-overexpressing breast cancer cells from trastuzumab-induced complement-dependent cytotoxicity

(2017) Yu Wang et al.   Oncology Letters

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

(2016) Nadja Alt et al.   BIOLOGICALS

Fc-galactosylation modulates antibody-dependent cellular cytotoxicity of therapeutic antibodies

(2016) Marco Thomann et al.   MOLECULAR IMMUNOLOGY

Fc glycans of therapeutic antibodies as critical quality attributes

(2015) Dietmar Reusch et al.   GLYCOBIOLOGY

In Vitro Glycoengineering of IgG1 and Its Effect on Fc Receptor Binding and ADCC Activity

(2015) Marco Thomann et al.   PLoS One

Multi-Angle Effector Function Analysis of Human Monoclonal IgG Glycovariants

(2015) Tetyana Dashivets et al.   PLoS One

Expert perspectives on biosimilar monoclonal antibodies in breast cancer

(2014) J. Cortés et al.   BREAST CANCER RESEARCH AND TREATMENT

Breast cancer in China

(2014) Lei Fan et al.   LANCET ONCOLOGY

Structural basis for improved efficacy of therapeutic antibodies on defucosylation of their Fc glycans

(2011) Tsunehiro Mizushima et al.   GENES TO CELLS

Acceptable changes in quality attributes of glycosylated biopharmaceuticals

(2011) Martin Schiestl et al.   NATURE BIOTECHNOLOGY