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Latest News
Monday, 12th April, 2021
Time : |
Recorded Webinar
Risks of not achieving comparability of biologics, mitigating risk & practices in Quality-Safety-Efficacy in proving comparability
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
Comparability during phase I, II, III, IV development of biologics has always been a challenge. Acceptability has sometimes been interpreted differently by the FDA and EMA. So much is known in the field of recombinant therapeutic proteins that the major regulatory authorities such as the EMA have been able to apply this knowledge to a new generation of biologics called "biosimilars".
Development of bisoimilars has enhanced both industries and regulators understanding of comparability, the potential issues, the risks and solutions. Therefore there is a feedback loop to the development of novel therapeutics, whether recombinant or not. Also, there is a better regulatory concensus of how an abbreviated program of studies can be used as basis of approval of "biobetters" and even highly novel biologics.
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