FDA’s New Biosimilars Plan - Webinar Recording/Transcript

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FDA’s New Biosimilars Plan: What’s the Deal With the Agency’s New Policy and What’s the Impact on Pharmaceutical Stakeholders

To date 12 biosimilar products have been approved by the FDA — but only 3 have reached the market.

The FDA’s Biosimilars Action Plan:

  • Lays out how the agency is modernizing regulatory policies
  • Accommodates new scientific tools to better enable comparison between biosimilars and reference products
  • Potentially reduces the need for clinical studies

FDAnews has enlisted the help of consultant Nitisha Pyndiah to spell out what you need to know — what the FDA is thinking, where the industry is heading, and how you can gain competitive advantage. Here are just a few of the specifics to be covered:

  • The key elements of the Biosimilars Action Plan — including balancing innovation and competition
  • Interchangeability vs. biosimilarity — understanding the differences under the BPCI Act
  • The development and implementation of new FDA review tools (i.e.: standardized review templates tailored to marketing applications for biosimilar and interchangeable products)
  • Enhancements to the Purple Book, including more information about approved biological products
  • The significance of the BsUFA II fees

You need to understand the FDA’s action plan and how it will affect your biosimilar product development.  Order today to get an insight into the different stakeholders opinion.

  • Executive suite
  • Strategic planners
  • Regulatory affairs
  • QA/QR/QC
  • Manufacturing executives
  • R&D
  • Marketing/sales
  • Legal counsel

Nitisha Pyndiah Ph.D. is a consultant with HartmannWillner where she provides Biotech Consulting Services to clients, including strategic support for development of biological, biotechnologica, and biosimilar products from preclinical development through the entire product lifecycle.