Biosimilars

The FDA has granted an approval to SB3 (Ontruzant; trastuzumab-dttb), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

Pamela N. Munster, MD, professor, department of medicine (hematology/oncology), University of California, San Francisco (UCSF), director, early phase clinical trials unit, co-leader, Center for BRCA Research, leader, Experimental Therapeutics Program, UCSF Helen Diller Family Comprehensive Cancer Center, discusses the developmental process for biosimilars in oncology.

Sara A. Hurvitz, MD, director of the Breast Oncology Program, medical director of the Clinical Research Unit, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses the importance of biosimilars in HER2-positive breast cancer.

Adam M. Brufsky, MD, PhD, discusses the impact of biosimilars in the field of oncology and outlined other strategies and steps that can be taken to mitigate cost when treating patients with breast cancer.

Out-of-pocket expenditures are substantially less among Medicare beneficiaries with breast cancer undergoing chemotherapy who receive prophylaxis for febrile neutropenia with a filgrastim biosimilar as opposed to the reference product.

Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discusses cost mitigation practices that can be implemented before more biosimilars reach the United States market.

Erika P. Hamilton, MD, director, Breast and Gynecologic Research Program, Sarah Cannon Research Institute, discusses the addition of biosimilars to breast oncology.

The FDA has granted an approval to CT-P6, a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer

Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera–SC Oncologia Medica in Genoa, Italy, discusses the financial benefit of biosimilars in oncology.

CT-P6, a proposed biosimilar to trastuzumab, exhibited long-term disease-free survival and overall survival similar to the reference product in the treatment of patients with HER2-positive early breast cancer.

Maurie Markman, MD, discusses the evolution of biosimilars and ongoing efforts to make treatments more affordable for patients with cancer.

Hans-Christian Kolberg, MD, head, Department of Obstetrics and Gynecology, Breast Cancer Center, and Gynecologic Cancer Center at Marienhospital Bottrop, Klinik für Gynäkologie und Geburtshilfe, Bottrop, Germany, discusses the importance of ensuring confidence with biosimilars in oncology.

Francisco J. Esteva, MD, PhD, medical oncologist, New York University’s Perlmutter Cancer Center, discusses the efficacy and safety of the trastuzumab (Herceptin) biosimilar candidate CT-P6 in HER2-positive breast cancer.

Aditya Bardia, MD, MPH, director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center, Harvard Medical School, discusses potential concerns regarding the use of biosimilars in the breast cancer space.

Patrick I. Borgen, MD, chair, Department of Surgery, director, Breast Cancer, Maimonides Medical Center, discusses the potential global impact of biosimilars in oncology.

Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford’s Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women’s Cancer Center, discusses the manufacturing process of biosimilars.

Adam M. Brufsky, MD, PhD, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, addresses biosimilar skepticism.

Patrick I. Borgen, MD, chair, Department of Surgery, director, Breast Cancer, Maimonides Medical Center, discusses the equivalence of biosimilars in oncology.

Mark D. Pegram, MD, Susy Yuan-Huey Hung Professor, co-director, Stanford’s Molecular Therapeutics Program, director, Breast Cancer Oncology Program, Stanford Women’s Cancer Center, discusses projections of cost reductions with biosimilars.

Andre Goy, MD, MS, chief, Division of Lymphoma, chairman and director, John Theurer Cancer Center, discusses the FDA approval of the rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy.

The FDA has approved the first rituximab biosimilar, CT-P10, for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy.

The European Commission has granted approval to the biosimilar Ziextenzo, a biosimilar for pegfilgrastim, as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy.

Maurie Markman, MD, president of Medicine and Science, Cancer Treatment Centers of America, editor-in-chief, OncologyLive, and 2018 Giant of Cancer Care® for Gynecological Cancers, discusses the concept of biosimilars in oncology.

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.

Mark D. Pegram, MD, highlights the gradually evolving landscape of biosimilars and provides insight on how they can shape the US market.