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Novartis Group calls on FDA to maintain the well-established naming policy for all biologics to help ensure patient safety
Date:10/30/2013

ach brand name having been vetted for distinctiveness and clarity by FDA.  FDA discourages the use of prefixes or suffixes in brand names because they are known to risk confusion and medication errors.

"Practitioners around the world have relied on the present naming convention for over 50 years, and the introduction of biosimilars does not warrant a change in this policy," said Mark McCamish, MD, Ph.D. Head of Global Development Biopharmaceuticals & Oncology Injectables at Sandoz. "As a leader in both innovative and generic medicines, we believe that a modified INN would thwart patient access and prevent the U.S. from receiving the full cost-saving benefits of biosimilars enjoyed in Europe and other highly-regulated markets." 

Since 1953, the World Health Organization (WHO) has administered the INN system, which groups drugs and biologics according to their active pharmaceutical ingredients. This system has been successfully used with biosimilars in highly-regulated markets across the globe, including Europe.

Novartis recognizes that the introduction of generic or follow-on medicines after patent expiration stimulates innovation within the industry, provides cost savings to the system, and increases patient access to critical medicines. Novartis, through Sandoz, its generic pharmaceutical division, is the pioneer and global leader in biosimilars, with over 50% share of all biosimilars approved in the highly regulated markets of U.S., Canada, Europe, Japan and Australia. Sandoz biosimilars are sold in over 50 countries and have generated over 100 million patient exposure days in experience.

About NovartisNovartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in '/>"/>

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