Biosimilars

Francisco J. Esteva, MD, PhD, director, breast medical oncology program, Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, discusses the future use of biosimilars in breast cancer within the United States.

The biosimilars realm of oncology has been surrounded by a burst of clinical and regulatory news this week, with the read out of phase III findings and extension data, legality issues, and more.

Sara Hurvitz, MD, associate professor, David Geffen School of Medicine, UCLA; medical director, Jonsson Comprehensive Cancer Center Clinical Research Unit; co-director, Santa Monica-UCLA Outpatient Oncology Practices; and director, Breast Cancer Clinical Trials Program, UCLA, discusses the potential global impact of biosimilars in breast cancer.

ABP 798, a rituximab (Rituxan) biosimilar, demonstrated clinical equivalency to reference rituximab in patients with CD20-positive B-cell non-Hodgkin lymphoma.

Adjuvant treatment with the trastuzumab biosimilar CT-P6 demonstrated comparable efficacy and safety to the reference product in patients with HER2-positive early breast cancer.

Peter Schmid, MD, PhD, lead at the Centre for Experimental Cancer Medicine, Barts Cancer Institute, discusses the role of biosimilars in oncology.

Jame Abraham, MD, director of the Breast Oncology Program at Taussig Cancer Institute, co-director of the Cleveland Clinic Comprehensive Breast Cancer Program, and professor of medicine, Cleveland Clinic Lerner College of Medicine, discusses improving access to cancer therapy with biosimilars.

Hans-Christian Kolberg, MD, discusses the design of the LILAC study, the cardiac safety profiles of ABP 980 and reference trastuzumab, and patient and provider comfort with ABP 980 in practice.

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 safety profile of ABP 980 (Kanjinti; trastuzumab-anns).

Francisco J. Esteva, MD, PhD, professor, Department of Medicine, director, Breast Medical Oncology Program, NYU Langone's Perlmutter Cancer Center, discusses the use of trastuzumab biosimilars in the treatment of patients with 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 phase III LILAC study, which examined ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab (Herceptin) biosimilar, in early-stage HER2-positive breast cancer.

Ali McBride, PharmD, MS, BCOP, Clinical Coordinator of Hematology/Oncology, The University of Arizona Cancer Center, and President-Elect of the Association of Community Cancer Centers (ACCC), discusses the potential impact of bevacizumab (Avastin) biosimilars in oncology.

Gary H. Lyman, MD, MPH, senior lead, Health Care Quality and Policy, Hutchinson Institute for Cancer Outcomes Research, member, Cancer Prevention Program, Public Health Services Division, and member, Clinical Research Division, Fred Hutchinson Cancer Research Center, discusses the presence of biosimilars on the market and their potential to reduce healthcare costs in the United States.

The FDA has approved PF-05280586, a biosimilar for rituximab, for the treatment of adult patients with CD20-positive B-cell non-Hodgkin lymphoma as a single agent or in combination with chemotherapy, or for patients with CD20-positive chronic lymphocytic leukemia in combination with chemotherapy.

The FDA has approved PF-06439535, a bevacizumab biosimilar, for the treatment of patients with metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.

Gary Fanjiang, MD, vice president of Biosimilars Global Development, Amgen, discusses the development of biosimilars and some of the clinical considerations related to their use.

The FDA has approved ABP 980 (Kanjinti; trastuzumab-anns), a trastuzumab biosimilar, for the treatment of patients with HER2-overexpressing breast cancer as well as HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, marking the fifth approval by the agency for a trastuzumab biosimilar.

Peter Schmid, MD, PhD, lead at the Centre for Experimental Cancer Medicine, Barts Cancer Institute, discusses challenges with biosimilars in oncology.

The European Medicines Agency has validated and accepted a marketing authorization application for the trastuzumab biosimilar HD201 (Tuznue), according to the developer Prestige BioPharma.

Sandoz has entered into an agreement with EirGenix, Inc., to commercialize the proposed trastuzumab biosimilar EG12014 for use as a treatment of patients with HER2-positive breast and select gastric cancers.

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 development of trastuzumab biosimilars.

A biologics license application has been resubmitted to the FDA for the pegfilgrastim biosimilar LA-EP2006 to decrease the incidence of infection from febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy.

Hope S. Rugo, MD, director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, discusses the regulatory process behind biosimilars in oncology.

Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the epoetin alfa biosimilar.

Gary H. Lyman, MD, MPH, medical oncologist, Fred Hutchinson Cancer Research Center, discusses the differences in approving a biosimilar and the original biologic product during the 2019 NCCN Annual Conference.