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Recorded Webinar
Executive Update of the US/EU status and opportunities of the new Biosimilars Product Class
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
Although the EMA is in its 9th year of review and approval of biosimilars, the FDA is now testing its regulatory framework.
The EU biosimilars experience has influenced the regulators view of all biologics worldwide and led to new sophistication.
EMA clinical basis of approval of 2013 and 2014 biosimilars of new product therapeutic classes monoclonal antibodies (infliximab), fertility (FSH) and insulins (glargine) and the current pipeline opens up exciting opportunities.
The presentation will cover the following areas:
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