IRVING, Texas–(BUSINESS WIRE)–Vizient,
Inc. today submitted
comments to the Food and Drug Administration (FDA) in response to
its published draft guidance on the nonproprietary naming of biological
products.
We applaud the FDA’s decision not to require the addition of suffixes to
the nonproprietary names of previously approved originator biologics as
well as transitional biological products. However, Vizient continues to
be concerned about the addition of suffixes to biosimilars and
originator reference products. Vizient believes these suffixes are not
only unnecessary, as existing identifiers can continue to be utilized to
differentiate products successfully, but will also add to the already
complex task of managing medication information. Further, the
inconsistent application of the naming requirements will continue to
contribute to provider reluctance to prescribe biosimilars.
“While the FDA has decided to not require suffixes for some products,
Vizient recommends that the FDA applies this decision to all biologics,
including biosimilars – and we look forward to continuing to work with
the FDA to support strategies that increase biosimilar adoption,
minimize health care costs and mitigate increasing drug expenditures to
preserve access to care on this important issue,” said Steven
Lucio, vice president, pharmacy solutions for Vizient.
Vizient believes that the introduction of biosimilars is a vital factor
in the effort to decrease health care expenditures and rein in the
rising costs of prescription drugs, and continues to support the
introduction and adoption of biosimilars as alternatives to originator
biologics. We hope that the FDA considers taking steps to address all
barriers, both large and small, that could limit uptake of biosimilars
and the opportunity for the realization of greater value for the U.S.
health care market and our members.
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 2019, 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.
Contacts
Media Contact
Angie Boliver
(972) 830-7961
[email protected]
