Related Experiment Video
Updated: Feb 8, 2026

In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Milestones over the development of SB3, a trastuzumab biosimilar
Xavier Pivot1, Igor Bondarenko2, Thiery Petit1
1Centre Paul Strauss, Porte de l'Hopital Strasbourg, France.
Abstract:
The development of a biosimilar requires large extensive preclinical and clinical comparability exercises to demonstrate equivalence to the reference medical product. The holistic results from this large assessment should be taken into account to appreciate the validity of the development and the interpretations. SB3 is the first trastuzumab biosimilar approved for routine use in Europe. The present manuscript reviews the development and the results of SB3, including clinical assessment and the clinical Phase I, as well as the large randomized Phase III comparing efficacy between SB3 versus Herceptin® containing regimen in neoadjuvant setting. Key points of the design and interpretations of the findings are extensively discussed in this review of SB3 development.
Related Concept Videos
Drug Products: Biologics, Biosimilars and Interchangeables
Sustainable Development
Development of the Lymphatic System
The first lymph sacs to form are the paired jugular lymph sacs located at the junction of the internal jugular and subclavian veins. From these sacs, lymphatic capillary plexuses extend to the thorax, upper limbs, neck, and head, eventually forming lymphatic vessels. Each jugular lymph sac maintains a...
Language Development
The critical period for language acquisition suggests that the ability to acquire language is at its peak early in life. As people age, this proficiency decreases. Language development begins very...
Development of Immunocompetence
The initial cells that migrate from the fetal thymus settle within the skin and epithelial tissues lining the mouth, digestive tract, and in females, the uterus and vagina. These cells, including skin-based dendritic cells, serve as antigen-presenting cells, playing a key role in T cell activation.
Subsequent T...
Development of the Heart
As the embryo undergoes lateral folding, these paired tubes approach each other, merging into a single primitive heart...

