Abstract
SB3 (Ontruzant®) is the first biosimilar of the reference anti-HER2 antibody trastuzumab to be approved in the EU. It is approved for use in all indications for which reference trastuzumab is approved, namely HER2-positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. SB3 has similar physicochemical and pharmacodynamic properties to those of reference trastuzumab, and the pharmacokinetic biosimilarity of the agents has been shown in healthy volunteers and women with HER2-positive early or locally advanced breast cancer. SB3 demonstrated clinical efficacy considered equivalent to that of reference trastuzumab in women with HER2-positive early or locally advanced breast cancer. The tolerability, immunogenicity and safety profiles of SB3 were similar to those of reference trastuzumab. The role of reference trastuzumab in the management of HER2-positive cancers is well established and SB3 provides an effective biosimilar alternative for patients requiring trastuzumab therapy.
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The preparation of this review was not supported by any external funding. During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the author on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
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The manuscript was reviewed by: P. Gascón Division of Medical Oncology, Hospital Clinic, University of Barcelona, Barcelona, Spain; G. Mustacci, Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
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Lamb, Y.N. SB3 (Ontruzant®): A Trastuzumab Biosimilar. BioDrugs 32, 293–296 (2018). https://doi.org/10.1007/s40259-018-0282-5
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DOI: https://doi.org/10.1007/s40259-018-0282-5