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Recorded Webinar

Biosimilars Advances in the Approvals of Biosimilars by The FDA Since Only in 4th Q 2015, and a Decade 2006-2017 of Approvals by the EMA

timelapse 60 Min with 15 Min QnA 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

The FDA have required bridging pharmacokinetic bioequivalence studies. Impressive is the FDA tackling monoclonal antibodies under abbreviated BLA’s before gaining more experience with simpler molecules, whereas in Europe these heterogeneous molecules were only submitted under MAA’s only after 6 years of first EU biosimilar approvals in 2006. However, the FDA were not able to approve peglyated filgrastim leading to withdrawal of the ABLA.

Meanwhile, after the EMA’s 10th year anniversary of biosimilar approvals, EMA have continued to approve representatives of new classes of biosimilars for haemolytic disorders and osteoporosis. Others, such as the first 2 oncology biosimilar mAbs, the first in a most difficult class of products, are under recent approval or assessment by the EMA, filed by a pioneering sponsor in the mAb field. Finally, FDA have published their long awaited interchangeability guidance in February, with huge implications.

This presentation aims to address some of the challenges and to encourage debate in the wider community

  • FDA draft guidance Jan 2017 Demonstrating Interchangeability
  • Insulin glargine Basaglar US submission
  • Comparing approved labels of biosimilar Zarxio ABLA 351k with Granix BLA 351a pathways (USA)
  • Navigating an optimal biosimilars development? Overcoming foreseeable barriers to approval?
  • Biosimilar Development US Pipeline
  • US approved biosimilars
  • Clinical safety of biologic comparatively Risk
  • FDA conditions for biosimilar interchangeable with reference (originator) product (RP), 2012 to 2016
  • Interchangeability, the 5th hurdle? Design?Our proposals in 2015


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