Key Takeaways
- Uncertainty about first interchangeable biosimilar exclusivity remains a concern for industry.
- The FDA is writing guidance, but has been forced to start over based on new fact patterns.
- A new FDA position that all approved biosimilars should be deemed interchangeable likely will create more legal issues to resolve.
The changing biosimilar landscape appears to be delaying US Food and Drug Administration policies that ideally would help boost the sector.
Sponsors want more information about first interchangeable biosimilar exclusivity, including how the agency will award it and events that could trigger it. But before a document can be completed, new...
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