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Recorded Webinar

FDA Interchangeability Requirements for Biosimilar “I” Rating, Permitting Pharmacy level Substitution

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

Dr Hoss will elucidate the FDAs position of a subclass of commercially advantageous subgroup of the biosimilar "B" rated biologicals, which will afford them an "I" substitutable rating in the FDAs 2015-established "Purple Book".

The presentation will cover the following areas:

  • The development of biosimilars carried out in parallel for the EU and the USA
  • FDA-defined "interchangeability" has been a priority for the major Biosimilar players
  • Statement of Section 351(i) of the US Public Health Services (PHS) Act
  • FDA guidance “Considerations in Demonstrating Interchangeability With a Reference Product”
  • Discuss on The 351(k) Pathway for Approval of Biosimilar
  • Guide us “All Therapeutic Protein Products”.
  • How to fulfil an FDA Approval of Biosimilarity
  • Importance of FDA - Key Considerations


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