Competition Quote by Scott Gottlieb
“Biologics must be grown in living systems - fermented, for example, in large vats of bacteria cells. This makes them hard to replicate. For decades, biologics weren't subject to competition from copycat generic medicines, even once patents and exclusivities had lapsed on originals.”
About This Quote
Source Speech: Interview on Biologics Industry, 2022
Biologics are produced using living organisms, making them complex and difficult to copy, so generics have struggled to compete even after patents expire.
In simple terms: Biologics are made in living cells, hard to copy.
Recognize the challenges of replicating biologics.
Themes
Mood
Type
When to use this quote
- drug development
- regulatory strategy
- market entry
- R&D planning
Key Concepts
Questions to Reflect On
- How can policy encourage affordable biologics?
- What alternatives exist to reduce reliance on complex manufacturing?
Complex manufacturing limits generic entry, raising costs.