The Novartis Group of companies, recently provided comments on the U.S. Food and Drug Administration (FDA) Proposed Rule entitled “Designation of Official Names and Proper Names for Certain Biological Products”.
As the first company to market a biosimilar in the US, Sandoz, a Novartis company, shares the FDA’s commitment to patient safety and to ensuring accurate perceptions of the safety and effectiveness of biological products.
Sandoz believes biosimilars and interchangeable biologics should share the same non-proprietary name as their respective reference products and that …