IRVING, Texas--(BUSINESS WIRE)--Vizient, Inc. yesterday submitted comments to the Food and Drug Administration (FDA) in response to its draft guidance, “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.”
We applaud the FDA’s draft guidance which clarifies that a comparative clinical immunogenicity study may not be necessary for approval of certain proposed biosimilar and interchangeable insulin products. Vizient believes FDA’s draft guidance will support a more effective and efficient approval process for biosimilar and interchangeable insulins by streamlining clinical data requirements.
“Vizient fully supports scientifically justified opportunities to improve approval processes for biosimilars and interchangeable biologics, including insulins,” said Steven Lucio, vice president, pharmacy solutions, for Vizient.
Vizient believes the approval of biosimilar and interchangeable biological products is a key mechanism to decrease health care expenditures and support competition among prescription drugs. “The approval of more insulin biosimilars will enable patients with diabetes to have much needed access to more affordable treatment options,” said Lucio.
Vizient encourages the FDA to continue to convene public hearings, such as “The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products,” held in May 2019. The event, which included a presentation from Vizient, helped inform the FDA’s draft guidance by identifying scientifically justified opportunities to improve patient access to biosimilars and interchangeable biologics.
Vizient is the nation’s largest member-driven health care performance improvement company, providing innovative data-driven solutions, expertise, and collaborative opportunities that lead to improved patient outcomes and lower costs.
About Vizient, Inc.
Vizient, Inc. provides solutions and services that improve the delivery of high-value care by aligning cost, quality and market performance for more than 50% of the nation’s acute care providers, which includes 95% of the nation’s academic medical centers, and more than 20% of ambulatory care providers. Vizient provides expertise, analytics and advisory services, as well as a contract portfolio that represents more than $100 billion in annual purchasing volume, to improve patient outcomes and lower costs. Vizient has earned a World’s Most Ethical Company designation from the Ethisphere Institute every year since its inception. Headquartered in Irving, Texas, Vizient has offices throughout the United States. Learn more at www.vizientinc.com.