Vizient, Inc. Applauds FDA’s Biosimilar Action Plan

Vizient, Inc. enthusiastically supports the U.S. Food and Drug Administration’s (FDA) newly unveiled 11-part Biosimilar Action Plan (BAP). Vizient has long been a vocal proponent of biosimilar approval, adoption and use and continues to provide education to encourage understanding of this developing market.

Vizient endorses FDA’s actions and agrees with its statement that patients “are the primary beneficiaries of this virtuous cycle of innovation and competition” that has been realized via the generic approval process and is now starting to materialize through biosimilars.

Vizient’s associate vice president of pharmacy services, Steven Lucio, recently released a book on the topic ("Biosimilars and Biologics," published by the American Society of Health System Pharmacists), where he highlights advances in biologic agents backed by evidence-based research and explores just how these innovative drugs are impacting practice. In addition, he was one of the featured panelists for a session on biosimilars at last week’s MedCity CONVERGE event in Philadelphia.

Biosimilar competition strengthens the healthcare market via increasing access to biologic therapy through lowering costs for patients and providers. While more streamlined than the approval pathway for originators, a biosimilar evaluation is both thorough and rigorous and maximizes the capabilities of analytical characterization to yield a product that is highly similar to the reference biologic in terms of safety, purity and potency.

Additionally, biosimilars approved in highly regulated markets like the U.S. and in Europe, have yielded the same clinical performance as their branded, originator counterparts. Therefore, we believe biosimilars have the potential to significantly lower the expense for biologic drugs that are currently cost prohibitive for many, while simultaneously maintaining a high level of quality and improved clinical outcomes.

“The interchangeability of biosimilars and innovator drugs may be difficult at first, but they greatly expand opportunities for health care organizations to better manage pharmaceutical spending," said Lucio. "Over the next few years, pharmaceutical cost savings attained through the use of biosimilars are expected to average 20-30 percent. It’s more important than ever that people make well-informed judgments about the use of these drugs.”

Of particular note, FDA is creating a distinct Office of Therapeutic Biologics and Biosimilars (OTBB) to improve coordination of all activities under the Biosimilar User Fee Act program. The FDA is also implementing numerous actions to increase efficiency of all aspects of approval. The agency also states a willingness to support a global biosimilars market through the harmonization of requirements for continued development and continues to convey the commitment to increased education of patients, clinicians, and payors. The FDA is also committing to the revision and/or finalization of multiple guidances previously published. One such example includes the finalization of the guidance for biosimilar labeling, published to coincide with the launch of the BAP.

Vizient is the nation’s largest health care performance improvement company serving a diverse membership that includes academic medical centers, pediatric facilities, community hospitals, integrated health care delivery networks and non-acute health care providers.

About Vizient, Inc.

Vizient, Inc., the largest member-driven health care performance improvement company in the country, provides innovative data-driven solutions, expertise and collaborative opportunities that lead to improved patient outcomes and lower costs. Vizient’s diverse membership base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents approximately $100 billion in annual purchasing volume. The Vizient brand identity represents the integration of VHA Inc., University HealthSystem Consortium and Novation, which combined in 2015, as well as MedAssets’ Spend and Clinical Resource Management (SCM) segment, including Sg2, which was acquired in 2016. In 2018, Vizient again received a World’s Most Ethical Company designation from the Ethisphere Institute. Vizient’s headquarters are in Irving, Texas, with locations in Chicago and other cities across the United States. Please visit www.vizientinc.com as well as our newsroom, blog, Twitter, LinkedIn and YouTube pages for more information about the company.

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