Thursday, September 19, 2019

Thursday, September 19, 2019

VIZIENT, INC.: Expresses Concern with FDA Policy on Naming of Biologic Medications


Vizient, Inc. issued the following announcement on May 7.

Vizient, Inc. today submitted comments to the Food and Drug Administration (FDA) in response to its published draft guidance on the nonproprietary naming of biological products.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.

Original source can be found here.

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