Dr. Callahan on the Potential Benefits of Biosimilars in Breast Cancer

Rena D. Callahan, MD
Published: Friday, Apr 27, 2018



Rena D. Callahan, MD, assistant clinical professor of medicine, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses the potential benefit of using biosimilars in the treatment of patients with breast cancer.

In addition to the lower cost, if a biosimilar meets the criteria set by the FDA, and there is not a significant difference in efficacy or toxicity, Callahan says it is a good thing for patients. Callahan says that considerations for using the biosimilar, such as the recently-approved trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) over the originator biologic include efficacy data, delivery method, cost, and patient participation.

In December 2017, the FDA approved MYL-1401O for use in patients with HER2-positive breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. This was based on the phase III results from the HERiTAge study. In the first part of the HERiTAge study, patients underwent a minimum of 8 cycles, with trastuzumab continuing until progression. Both forms of trastuzumab were administered with a loading dose of 8 mg/kg and a maintenance dose of 6 mg/kg every 3 weeks.


Rena D. Callahan, MD, assistant clinical professor of medicine, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses the potential benefit of using biosimilars in the treatment of patients with breast cancer.

In addition to the lower cost, if a biosimilar meets the criteria set by the FDA, and there is not a significant difference in efficacy or toxicity, Callahan says it is a good thing for patients. Callahan says that considerations for using the biosimilar, such as the recently-approved trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) over the originator biologic include efficacy data, delivery method, cost, and patient participation.

In December 2017, the FDA approved MYL-1401O for use in patients with HER2-positive breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. This was based on the phase III results from the HERiTAge study. In the first part of the HERiTAge study, patients underwent a minimum of 8 cycles, with trastuzumab continuing until progression. Both forms of trastuzumab were administered with a loading dose of 8 mg/kg and a maintenance dose of 6 mg/kg every 3 weeks.

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: Bridging the Gaps Around Oncology Biosimilars: Assessing the Potential Impact of Emerging Agents to PracticeSep 29, 20181.5
Advent of Oncology Monoclonal Antibody Biosimilars ‒ A European Perspective OnlineNov 30, 20183.0
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