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Recorded Webinar

Executive insights into the FDA "Purple Book" Classification and other FDA initiatives regarding biologics and biosimilars - Including background to very first two 351k ABLA (2014) submissions to FDA

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 setting up its whole regulatory framework only now which started in 2012.

The EU biosimilars experience has influenced the regulators view of all biologics and led to new sophistication. The EMAs impact wordwide had been remarkable as a result. The webinar will explore, at a strategic level, progress in the US, the implications of the Purple Book, and various FDA guidances colelctively, the recent clinical pharmacology one, and interchangeability. Also provided would be the EMA clinical basis of approval of 2013 biosimilars and the current most eminent pipeline. The current first 351k ABLA reviews by the FDA of filgastrim Zarzio and infliximab Remsima are bridging submissions to the EU summary basis of approval, so there is merit in reviewing those and even more recent cases a FSH and a glargine.

Areas Covered in the Webinar:

  • The implications of the Purple Book
  • Various FDA guidances colelctively the recent clinical pharmacology one and interchangeability
  • EMA clinical basis of approval of 2013 biosimilars and the current most eminent pipeline
  • The current first 351k ABLA reviews


Apply for this webinar

Who should attend

Anyone who is involved in biosimilars, regulatory/quality, drug development etc.

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