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Vizient, Inc. Endorses the FDA’s Biosimilars Approval Pathway

Letter of support sent to the FDA’s Arthritis Advisory Committee Reviewing Biosimilar Infliximab

Category:

02/05/16

Dateline:

IRVING, Texas

IRVING, Texas--(BUSINESS WIRE)--Citing the escalating costs for certain commonly used biologics and the associated expenses for its members of over $6 billion, Vizient, Inc. has sent a letter to the Food and Drug Administration’s (FDA) Arthritis Advisory Committee endorsing the continued implementation of the U.S. biosimilar pathway. On February 9, 2016, the committee is scheduled to hold an advisory hearing on an application for a biosimilar version of infliximab, currently only available as the branded biologic Remicade® (Janssen Biotech).

“Infliximab is only the second biosimilar application to have made it to an advisory committee hearing. Although infliximab is a more complex biologic, Vizient wanted to reiterate our support for the FDA’s key principles within their biosimilar approval pathway and the underlying science that is intended to substantiate the safety and efficacy of these products across their range of clinical applications,” said Steven Lucio, senior director, clinical solutions and pharmacy program development.

From Vizient’s perspective, it’s critically important that some much needed pricing relief be made available for providers and patients for infliximab and other filed biosimilar applications. Even a modest price reduction of between 20% and 30% would mean price relief in the neighborhood of $1.2 billion to $1.8 billion for these drugs. In light of the well-publicized price increases that drug companies are imposing on customers in recent months, an opportunity to provide some much needed pharmaceutical pricing relief should be championed.

In the letter, Vizient notes that over the last five years the company has worked to educate the pharmacists, physicians and other clinicians across its membership of 5,200 health systems and affiliates, which include community hospitals, academic medical centers, pediatric hospitals, and approximately 167,000 non-acute facilities, of the concepts of biosmilarity determination.

About Vizient, Inc.

Effective April 1, 2015, VHA, the national health care network of not-for-profit hospitals, and UHC, the alliance of the nation’s leading academic medical centers, combined into a single organization, Vizient. Vizient also includes Novation, the health care services company they already jointly own. Vizient is the largest member-owned health care company in the country and is dedicated to leading health care innovation, creating knowledge and fostering collaboration to help our members thrive. The company serves more than 5,200 health system members and affiliates as well as 167,000 non-acute health care customers. Members range from independent, community-based health care organizations to large, integrated systems and academic medical centers, and it represents more than $60 billion in annual purchasing volume. Headquarters are in Irving, Texas, with locations in Chicago and other cities across the United States.

Contact:

Vizient, Inc.
Donna Ledbetter, 972-830-6321
Donna.ledbetter@vizientinc.com

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