Dr. Rugo on the Optimal Setting for Biosimilar Evaluation

Hope Rugo, MD, professor of medicine, director of the Breast Oncology Clinical Trials Program, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the optimal setting for biosimilar evaluation.

In an analysis of trastuzumab (Herceptin) biosimilars in breast cancer, investigators compared studies in the neoadjuvant and metastatic settings to determine which setting was more favorable for testing biosimilars. Half of the studies evaluated were in the neoadjuvant setting, while the other half were in the metastatic setting. By closely considering the way in which the studies wereconducted as well as the results they yielded, Rugo felt that they would be able to answer this question.

Investigators found that the neoadjuvant and metastatic settings are equally good settings to evaluated biosimilarity. Data collected in both settings could be used to extrapolate the use of trastuzumab biosimilars in other settings, with other combinations, and in other diseases in which trastuzumab is used, she adds. Rugo notes that patients in each group were relatively homogenous in terms of amount of visceral disease.

This information is beneficial, Rugo adds, as it may lead to trastuzumab biosimilar availability in countries that cannot afford the originator biologic.