Fiche publication
Date publication
juin 2018
Journal
Future oncology (London, England)
Auteurs
Membres identifiés du Cancéropôle Est :
Pr PETIT Thierry
,
Pr PIVOT Xavier
,
Dr CURTIT Elsa
Tous les auteurs :
Pivot X, Bondarenko I, Petit T, Curtit E
Lien Pubmed
Résumé
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.
Mots clés
biosimilar, breast cancer, trastuzumab
Référence
Future Oncol. 2018 Jun 21;:
