Monday, August 13, 2012

Biosimilars Spotlight: Are Novel Names for Biosimilars Important?

Recently the Business of Biosimilars and Generic Drugs team sat down with Mark McCamish, the Global Head of Biopharmaceutical Development, Sandoz International, a Division of Novartis to discuss the current state of biosimilars and many of the regulations,or lack there of, facing the United States.

If biosimilars require the use of novel names, what could biosimilar companies do to try to turn that into a marketing advantage?

Mark's Answer:
I think there were misunderstandings early on when addressing the International Nonproprietary Name or INN. Novartis was very supportive from the beginning to use the same naming convention that is currently being used with all biologics in that they would have a unique proprietary name (for example the brand name). They would also use the INN or the generic name of the original molecule. When Novartis said that we wanted to use the same INN as the originator molecule (as would be done in all other conventions), we did not imply that we would brand our products with the INN or the generic name. We are global leaders in the commercialization of biosimilars and each one of our biosimilars has a unique brand name and then has the standard INN of the originator molecule. And that’s what we have been supportive of in the US. In reality, we do support a unique proprietary name, a unique brand name, but rely on using the same INN as the originator.
Some people have spoken on this and they’ve suggested the use of a unique INN different from the originator, which would be a little bit challenging from a track and trace and from a safety perspective because doctors and patients and payers really don’t know if they are getting the same product as the originator or not. We’ve been presenting this information in a straight forward fashion to convince FDA of the wisdom of using the same naming convention that they’ve used in all other biologics.

For access to the entire podcast and transcript, download it here.

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