Biosimilars

Adam M. Brufsky, MD, PhD, FACP, discusses the emergence of biosimilars in oncology and how he anticipates they will change the paradigm.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for the rituximab biosimilar PF-05280586 for the treatment of patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

Three biosimilars—bevacizumab-bvzr (Zirabev), rituximab-pvvr (Ruxience), and trastuzumab-qyyp)—will become available in the United States at a substantial discount to their reference products.

Ruth O’Regan, MD, and Adam M. Brufsky, MD, PhD, FACP, both discuss the emergence of trastuzumab biosimilars in breast cancer.

Francisco J. Esteva, MD, PhD, discusses the cost-saving potential of biosimilars in breast cancer and historical experience with their use.

Julie R. Gralow, MD, discusses the emergence of biosimilars in the United States and globally.

A biologics license application has been submitted to the FDA for the rituximab biosimilar ABP 798.

Christopher A. Klebanoff, MD, discusses using biosimilars to reduce financial toxicity in breast cancer.

Megan Kruse, MD, discusses how to converse with patients with breast cancer about implementing biosimilars in treatment.

Julie R. Gralow, MD, discusses the science of biosimilars and their implementation in breast cancer.

Massimo Cristofanilli, MD, discusses the need for biosimilars in oncology.

John M. Pagel, MD, PhD, discusses the use of biosimilars in oncology and the importance of cost consciousness.

John Hays, MD, PhD, discusses the potential for PARP inhibitor combinations in patients with ovarian cancer.

Herbert A. Eradat, MD, discusses the implications of the FDA approval of rituximab-pvvr (Ruxience), a biosimilar to rituximab (Rituxan) in patients with CD20-positive B-cell Non-Hodgkin lymphoma and chronic lymphocytic leukemia.

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, discusses the potential utility of biosimilars in oncology.

Gregory Vidal, MD, PhD, discusses how the field will determine which trastuzumab (Herceptin) biosimilar to prescribe in clinical practice.

The trastuzumab biosimilar Ogivri (MYL-1401O; trastuzumab-dkst) has been launched in the United States for all indications of the reference product, including the treatment of patients with HER2-overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator, Hematology/Oncology, The University of Arizona Cancer Center, clinical assistant professor, The University of Arizona College of Pharmacy, discusses the regulatory pathway for biosimilars in oncology.

Jim M. Koeller, MS, FHOPA, discusses the inherent variability of recombinant DNA technology behind biosimilars.

Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, discusses factors that need to be taken into consideration as biosimilars emerge in oncology.

The Chinese-manufactured trastuzumab biosimilar HLX02 demonstrated similar objective response rates to the reference product at 24 weeks in patients with treatment-naïve or recurrent metastatic HER2-positive breast cancer.

Bradley G. Somer, MD, discusses the importance of taking a proactive approach towards the use of biosimilars in oncology.

Lee S. Schwartzberg, MD, FACP, discusses the development and approval process for biosimilars and explains how their availability could drive down out-of-pocket costs for patients.

Bradley G. Somer, MD, discusses the education surrounding biosimilars in oncology.

Mark E. Robson, MD, discusses the importance of educational efforts aimed at understanding the differences between biosimilars and biologics in oncology.

The FDA has accepted a biologics license application for the proposed bevacizumab biosimilar SB8.

Bradley G. Somer, MD, discusses the emergence of biosimilars in oncology

Kurt W. Tauer, MD, FACP, discusses the potential implications of biosimilars on cancer research funding.

Bradley G. Somer, MD, associate professor, Department of Hematology and Medical Oncology, University of Tennessee Health Science Center, medical oncologist, senior partner, Executive Cancer Council, and head of strategic expansion/development, West Cancer Center Research Program, West Cancer Center, explains where the hesitancy regarding biosimilar use in oncology.

Lee S. Schwartzberg, MD, FACP, explains how biosimilars could lead to increased competition in oncology.