Biosimilars

Yelena Novik, MD, associate professor, Department of Medicine, New York University’s Perlmutter Cancer Center, discusses the adoption of biosimilars in breast 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 central pathology review of the trastuzumab (Herceptin) biosimilar ABP 980.

The market for biosimilar introduction is “extremely unstable,” but the FDA is working to ease the launch of more affordable cancer medicines with a strategy that includes an attempt to reduce anticompetitive behavior.

Michael A. Savin, MD, assistant professor of medicine, School of Medicine, Oregon Health and Science University, discusses the evolution of biosimilars.

Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses the promise of trastuzumab (Herceptin) biosimilars.

Michael A. Savin, MD, assistant professor of medicine, School of Medicine, Oregon Health and Science University, discusses the future of biosimilars in oncology.

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 LILAC study of the biosimilar ABP 980.

Haythem Y. Ali, MD, discusses the state of biosimilar development and implementation in the field of oncology.

The pathologic complete response rate associated with the trastuzumab biosimilar ABP 980 was equivalent to that of reference trastuzumab based on central laboratory evaluation in patients with HER2-positive early breast cancer enrolled in the phase III LILAC study.

MYL-1401O (Ogivri; trastuzumab-dkst) added to a taxane as initial therapy followed by MYL-1401O monotherapy as maintenance resulted in a nearly identical rate of progression-free survival compared with trastuzumab (Herceptin) in patients with HER2-positive metastatic breast cancer.

The bevacizumab biosimilar PF-06439535 demonstrated similarity to the European Union bevacizumab reference product for overall response rate, with similar pharmacokinetic and immunogenicity profiles for patients with advanced non-squamous non-small cell lung cancer.

Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses the potential role for trastuzumab (Herceptin) biosimilars.

Alex E. Denes, MD, associate professor of medicine, School of Medicine, Oregon Health and Science University, discusses the use of biosimilars in the treatment of patients with cancer.

Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses the impact of the FDA-approval of the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst).

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses misconceptions about biosimilars in oncology.

Elisavet Paplomata, MD, discusses ABP 980 and the impact that biosimilars may have on global access to cancer care.

Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses the FDA approval process for biosimilars.

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses the incorporation of biosimilars into cancer treatment.

The FDA has approved epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, discusses challenges with integrating biosimilars into practice.

The FDA has issued a complete response letter to Sandoz (Novartis) regarding a biologics license application for the rituximab biosimilar GP2013.

Dennis J. Slamon, MD, PhD, director, Clinical/Translational Research, Revlon/University of California, Los Angeles (UCLA) Women's Cancer Research Program, Jonsson Comprehensive Cancer Center, UCLA, discusses the future of biosimilars in oncology.

Sara 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 when to use a biosimilar over the originator drug.

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.

Sara A. Hurvitz, MD, director of the Breast Oncology Program at the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, discusses the clinical use of biosimilars in oncology.