Duration of webinar : 60 Mins | Duration of Q/A session : 10-15 mins
Deliverables : Copy of presentation slides will be shared |
The Biologics Price Competition and Innovation Act of 2009 established a pathway for biological products that are similar to a novel product. The intent of this abbreviated pathway was to balance innovation and affordability in the same manner that the Drug Price Competition and Patent Restoration Act of 1984 did for generic drugs. This webcast will discuss the scientific and regulatory requirements for the development and approval of biosimilars and interchangeable biological products, requirements for the reference product, the totality-of-the-evidence approach, immunogenicity, clinical studies, and therapeutic and pharmaceutical equivalence.
This presentation will cover the following areas :
- Biosimilarity
- Comparability
- Interchangeability
- Therapeutic and Pharmaceutical Equivalence
- Totality of the evidence approach
- Reference product
- Regulatory mechanisms
- Clinical Trials
- Immunogenicity
- Labeling
- PDUFA goals, timelines, and fees
- Implement site selection tools & best practices
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Best Regards.
Marketing.
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