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.Today's Question: What do you consider to be the most important take away points in the current FDA draft guidelines? What developments are you most hoping to see in the next iteration?
Mark's Answer:
I think the key take away points from the current FDA draft guidelines are that they show flexibility, they have a step-by-step approach, and they have a science-based understanding. With that flexibility a sponsor such as Sandoz can come in and discuss their analytical characterization and their biologic characterization of their molecules, which is a foundation for appropriate reduction of clinical trials and pre-clinical trials. The draft guidances did show flexibility and if that flexibility can be woven into the final draft/the final guidances, it will be a step for FDA in terms of helping us in the development and commercialization of biologics.
There are some challenges that still remain. Interchangeability wasn’t addressed and there were some challenges potentially in some of the clinical trial scenarios addressing immunogenicity. So, those have to be further refined. But, we appreciated the flexibility, the step-by-step approach and a reliance on the analytical characterization of the molecules themselves.
For access to the entire podcast and transcript, download it here.
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