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Recorded Webinar
A EU/US Regulatory and Technical Practical Perspective on a Comparability Campaign of Quality and Biological (In vitro) Testing Studies in Support of Biosimilarity
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
A well-executed series of systematic chemistry, manufacturing and control (CMC) studies
is fundamental to biosimilars development and approval in the EU, and is expected to play
an important and fundamental part in future aBLA submissions in the US, as proven by
FDA’s emphasis in the February 2012 published draft dedicated scientific considerations guidance and quality guidance.
This will be explained and exemplified by laboratory findings.
- Current advances in chemistry, biochemical and biophysics structural and analytical methods, as well as biological in vitro and in vivo testing, allow head-to-head comparisons to be made to the reference medicinal product (RMP) biologics both at the drug product (DP) level upon release and during stability testing (accelerated or stress release testing is recommended).
- Comparing the EU experience with the FDA guidance, it will be shown that they are consistent and in agreement.
- If the biosimilar shows high “similarity,” FDA propose that the sponsor may have an appropriate scientific basis for a selective and targeted approach to subsequent animal and/or clinical studies. This basis is the same for the EMA, which allow a step wise development of nonclinical and clinical studies with increasing complexity, depending upon the foundation of biosimilarity as laid down by a thorough CMC comparability campaign.
Who should attend
Anyone who is involved in biosimilars, regulatory/quality, drug development etc.
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