Skip navigation
Analytical Procedures & Methods Validation Europe

Biosimilars Nomenclature and Implications for the U.S. Biopharmaceutical Industry

The next major controversy regarding biosimilars is product nomenclature. The names to be used in commerce for biosimilars affect the underlying perceptions about these products (how unique, innovative, generic or not they are), and largely control how they can be marketed. Uniquely-named products require marketing much like any innovator product, with no indication it is a biosimilar product. Similar names identify products as biosimilar, facilitate switching to biosimilars and involve minimal marketing (like generic drugs). Recent legislation totally avoids the issue of names and the FDA is expected to go with unique names for every product, until a true biogeneric  is approved. In this session, we explore what type(s) of name(s) FDA may use for biosimilars, the names to be used for other purposes, and how these impact the interests of different user communities.

  • Explore nomenclature considerations for biosimilars:

* how names control perception and marketing
* how unique or generic, meaningful or meaningless should names be?
* current nomenclature systems and options
* vastly conflicting needs of different user communities

  • Who will propose, control and track names? Who will win, and who will lose?

Ronald A. Rader
President
Biotechnology Information Institute