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Recorded Webinar
Harmonization in Biosimilars: EU and FDA Acceptance of Foreign Reference Products
timelapse 60 mins with 10-15 mins 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
EU Commission/EMA to accept non-EU or non-EEA reference medicinal product for biosimilar MAAs
European biosimilars developer have been faced with a legal requirement to use an originators reference product approved by and used in the EU in conducting studies to demonstrate biosimilarity. The EMA has recently announced that it will accept some clinical tests using reference product materials of foreign origin.
This presentation will cover the following areas :
- Current information about the new EMA policy and it potential effects on the newly released EU guidances on biosimilars containing monoclonal antibodies (mAbs) and other proteins.
- The biosimilar consultation “cluster” of the EMA and FDA will make advancement with this announcement. This opportunity will be explained
- Examples of implications of the new policy in drug development.
- Approaches to approval of biosimilars in the EU and US in light of the newly announced EMA policy.
- This webinar and dialogue will focus on the far reaching importance of the new EMA policy to allow foreign reference products.
- The regulatory and legal experts speakers will provide strategic insights into the impact of EMA announcement on biosimilars international development particularly US/EU.
Who should attend
Biotech and Pharma companies/professionals interested in Biosimilars/Biologics/Biomarkers including:
- Biosimilar Strategies
- Clinical Affairs
- Business Development
- Product Development
- Project Management
- Regulatory Affairs
- Sales and Marketing
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