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Recorded Webinar
FDA - Important Aspects to Consider When Determining Interchangeability
timelapse 60 Min with 15 Min QnA of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
On January 17, 2017, FDA released the long-awaited draft Guidance for Industry to help firms understand the considerations FDA deems necessary to prove interchangeability between an approved reference product and a proposed, less-expensive biologic.
Obviously, it’s critical for industry to understand the points addressed in this new guidance:
- What does FDA expect from manufacturers who feel they have a product which can be approved as interchangeable under the BPCI Act?
- What are the differences between biosimilar and interchangeable biologics?
- What studies are needed to demonstrate biosimilarity?
Key Areas Covered During the Webinar:
- Understand key definitions
- How to demonstrate interchangeability?
- Why immunogenicity is important to consider for interchangeable products?
- What are the factors affecting immunogenicity and how to mitigate the risks.
- How to design studies required to demonstrate interchangeability?
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