Sandoz comments on the FDA’s proposed rule for Designation of Official Names and Proper Names for Certain Biological Products
Nov 19, 2015
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 suffixes are not necessary.
The existing naming system for biological products in the US has worked well for more than 60 years with 77 commercially available biologic products already sharing 25 non-proprietary names. To our knowledge, there is no evidence of any safety concern resulting from inadvertent substitution of different biological products sharing the same non-proprietary name. In contrast, there is ample evidence that the current system in which biological products share non-proprietary names has worked well, with the vast majority of adverse event reporting occurring via brand name.
Introduction of suffixes to the non-proprietary names of biologics is not necessary and will be problematic. If FDA does impose the addition of suffixes to the non-proprietary names of biologics, it is important that the suffix be memorable, preferably derived from the name of the company that licensed the biologic. Evidence reveals that random letter suffixes will not be well remembered, defeating the stated FDA purposes of safety and enhanced pharmacovigilance. To further enhance memorability in the event that suffixes are imposed, all biologics, biosimilars and interchangeable biologics licensed by a given company should share the same suffix. If a suffix will be used, the suffix of an interchangeable biologic should be distinct from the reference product.