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Lancet Oncology Multi-Part Study on Oncology Drug Safety in the 21st Century Reveals the Need for New Approaches to Biosimilar and Generic Oncology Drugs

Much reform is needed before these new oncology drugs are safe, effective, affordable choices for U.S. patients

The Woodlands, Texas (November 2, 2016)The US Oncology Network, one of the nation’s largest networks of integrated, community-based oncology practices dedicated to advancing high-quality, evidence-based cancer care, is calling attention today to an important series of articles on pharmaceutical safety recently published by The Lancet Oncology, a leading peer-reviewed medical journal reporting on global clinical oncology research. The three-part series focuses on the need for new approaches to biosimilar and generic oncology drugs, while also examining the safety of these agents. Biosimilars and generics are viewed as logical solutions to control the increasing costs of cancer treatment, but as the articles reveal, much work must be done before these oncology drugs can become viable treatment options for patients in the U.S.

“It is exciting to see progress being made in biosimilar and generic drugs because they hold so much potential to help us drive down treatment costs,” said Robert Rifkin, MD, FACP, oncology researcher and medical oncologist with Rocky Mountain Cancer Centers in Denver. “However, there are still barriers to overcome before we can fully realize the benefits these new drugs can provide. We need a streamlined approach to how we develop, regulate, manage and promote acceptance of these drugs to physicians and patient consumers,” he noted. Rocky Mountain Cancer Centers is an affiliate of The US Oncology Network, and Dr. Rifkin is a leading researcher in the organization.

Safety and efficacy of biosimilars in oncology,” was published November 2, 2016. The research was conducted by H. Schellekens, MD, Department of Pharmaceutical Sciences, Utrecht University, Netherlands, Dr. Rifkin, and other collaborators. The study extensively reviews the safety of oncology biosimilars designed to be similar to originator and expensive oncology biologics, such as filgrastim and epoetin. The researchers conclude the lower cost versions are safe and effective throughout Europe, and their use is expanding to the U.S. They also suggest that going forward, oncology biosimilars will receive regulatory approvals with less extensive clinical testing, as analytic testing has greatly progressed over the last decade.

“Together, this article provides much-needed information to America,” said Dr. Rifkin. “The hope has always been that these biosimilar drugs could help us control the rapidly escalating costs of cancer treatment and increase patient access. Maintenance of transparency in the review process and balance of scientific rigor with efficiency will be essential to maximize end user confidence. Significant retooling is needed if these oncology drugs are to be safe, effective, and affordable choices for patients here in the U.S.,” he concluded.

About The US Oncology Network

The US Oncology Network is one of the nation’s largest networks of integrated, community-based oncology practices dedicated to advancing high-quality, evidence-based cancer care. A physician-led organization, The US Oncology Network unites like-minded physicians and clinicians around a common vision of improving patient outcomes and quality of life. Leveraging healthcare information technology, shared best practices, evidence-based guidelines and quality measurements, physicians within The US Oncology Network are pioneering new ways to achieve this vision. This includes participation in initiatives that are leading the way toward value-based care such as the Center for Medicare & Medicaid Innovation (CMMI) Oncology Care Model (OCM). The US Oncology Network is committed to strengthening patient access to integrated care in local communities across the nation, including collaboration with a variety of payers, hospitals and academic institutions. The US Oncology Network is supported by McKesson Specialty Health, a division of McKesson Corporation focused on empowering a vibrant and sustainable community patient care delivery system. For more information, visit

Media Contact
Claire Crye
The US Oncology Network