Biosimilars Regulation: The Importance of Interchangeability - Webinar CD/Transcript

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Biosimilars Regulation: The Importance of Interchangeability - Decoding FDA’s Definition—and Making It Work for Your Company

The biosimilars industry is at a crossroads known as interchangeability. Drug and biologics firms that are first to master this key concept stand to reap the greatest rewards.

This presentation breaks down the concept of interchangeability into competitive terms. You’ll discover how the FDA interprets interchangeability ... what manufacturers like you need to understand… and what comes next.

Your guides are consultants Suzanne Sensabaugh and Nitisha Pyndiah, thought leaders who’ve torn apart the FDA’s key guidance known as “Considerations in Demonstrating Interchangeability with a Reference Product.” They’ll explain what the guidance says ... and what it leaves unspoken.

During the course of this 90-minute presentation, you’ll gain mastery of highly technical sticking points so important to competitive success in biosimilars, including:

  • What you think interchangeability is, vs. what the FDA thinks it is
  • The most challenging areas of product development — including technical issues of similarity in purity and potency — and how to comply
  • How the FDA evaluates immunogenicity, a key factor entailing communication and cooperation with scientific colleagues
  • The chemistry of structural features, another key factor
  • Interchangeability vs. biosimilarity: Understanding the differences
  • And much more!

The first players to master interchangeability gain a huge advantage: the grant of additional layers of exclusivity from the FDA. The subject is complex, but time is short.

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

Meet Your Presenters

Suzanne M. Sensabaugh is President and Principal Consultant of HartmannWillner. She boasts 25+ years of experience in regulatory affairs, drug development and FDA compliance, with a focus on biologics, biosimilars and biologics/device combination products. Her experience includes stints at the FDA, pharma and as a consultant focusing on regulatory affairs.

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.