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Recorded Webinar

Scientific and Regulatory Issues in the Demonstration of Biosimilarity and Interchangeability

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

The Biologics Price Competition and Innovation Act of 2009 established a pathway for biological products that are similar to a novel product. The intent of this abbreviated pathway was to balance innovation and affordability in the same manner that the Drug Price Competition and Patent Restoration Act of 1984 did for generic drugs. This webcast will discuss the scientific and regulatory requirements for the development and approval of biosimilars and interchangeable biological products, requirements for the reference product, the totality-of-the-evidence approach, immunogenicity, clinical studies, and therapeutic and pharmaceutical equivalence.

This presentation will cover the following areas :

  • Biosimilarity
  • Comparability
  • Interchangeability
  • Therapeutic and Pharmaceutical Equivalence
  • Totality of the evidence approach
  • Reference product
  • Regulatory mechanisms
  • Clinical Trials
  • Immunogenicity
  • Labeling
  • PDUFA goals, timelines, and fees
  • Implement site selection tools & best practices


Apply for this webinar

Who should attend

Anyone who is interested in learning more on Scientific and Regulatory Issues

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