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Dr. Rugo Discusses a Comparative Review of Trastuzumab Biosimilars

Hope Rugo, MD
Published: Saturday, Oct 27, 2018



Hope Rugo, MD, professor of medicine, director of the Breast Oncology Clinical Trials Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses a comparative review of trastuzumab (Herceptin) biosimilars.

In a poster presented during the 2018 ESMO Congress, abstracts that included the terms “biosimilar” and “trastuzumab” published from January 1, 2013, to March 14, 2018 were pooled. In total, 8 phase II clinical trials for 6 investigational biosimilars were reviewed after selection for studies with sufficient comparative clinical efficacy results.

Rugo says this was done to look at any potential evidence that one setting was preferable to study biosimilarity over another. This is because there has been some discussion of trastuzumab biosimilars showing a better response in the neoadjuvant setting versus the first-line metastatic setting. Rugo explains that the regulatory guidance for looking at biosimilars is to choose a very sensitive indication and a short-term endpoint. This is to deter the creation of huge studies that evaluate progression-free survival, disease-free survival, and overall survival.


Hope Rugo, MD, professor of medicine, director of the Breast Oncology Clinical Trials Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses a comparative review of trastuzumab (Herceptin) biosimilars.

In a poster presented during the 2018 ESMO Congress, abstracts that included the terms “biosimilar” and “trastuzumab” published from January 1, 2013, to March 14, 2018 were pooled. In total, 8 phase II clinical trials for 6 investigational biosimilars were reviewed after selection for studies with sufficient comparative clinical efficacy results.

Rugo says this was done to look at any potential evidence that one setting was preferable to study biosimilarity over another. This is because there has been some discussion of trastuzumab biosimilars showing a better response in the neoadjuvant setting versus the first-line metastatic setting. Rugo explains that the regulatory guidance for looking at biosimilars is to choose a very sensitive indication and a short-term endpoint. This is to deter the creation of huge studies that evaluate progression-free survival, disease-free survival, and overall survival.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective OnlineNov 30, 20183.0
Community Practice Connections™: Evaluating the Emerging Role of Biosimilar Agents for the Treatment of Hematologic MalignanciesMar 08, 20193.0
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