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FDA Public Hearing : Approval Pathway for Biosimilar and Interchangeable Biological Products
- 등록일2010-11-09
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FDA_Public_Hearing.pdf
FDA Public Hearing :
Approval Pathway for Biosimilar and Interchangeable Biological Products
Key Issues
1. Biosimilarity
2. Interchangeability
3. Patient Safety and Pharmacovigilance
4. Maintaining Incentives for Innovation
Biosimilarity
● Comparative analytical, nonclinical, and clinical studies are necessary to protect patient safety
- In particular, clinical immunogenicity testing is necessary
- Should compare active ingredients and compare formulated drug products
● Structural requirements for identity should be stringent
● The scope of clinical studies depends on factors including the findings and limitations of analytical and nonclinical studies, and the state of public knowledge
● Differences have to be scientifically justified
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