Evolving Biosimilar Pathway Brings Mid-Review Policy Issues
Executive Summary
Drug Review Profile: Labeling, unique fee structure among many challenges that Inflectra sponsor Celltrion and FDA had to navigate in nascent regulatory pathway.
Topics
- Subjects
- Approvals
- Drug Review
- Biosimilars
- Industries
- BioPharmaceutical
- Regions
- North America
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PS118739
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PS118739
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