Considerations for real-world approaches for biosimilar evidence generation needs

1 hour, 2 minutes

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November 18, 2015

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Sponsors of biosimilar products have to demonstrate that they are similar or highly similar versions of a marketed biologic. They hold the promise of reducing healthcare costs, increasing patient access and promoting innovation. With the increasing number biologic patents expiring, the availability of biosimilars is expected to increase across the globe. As the biosimilar landscape continues to evolve, manufacturers face an increasingly sophisticated marketplace. In addition to the required comparative analytical, nonclinical and clinical studies, relevant real-world clinical evidence is often required to fill evidence gaps and to support claims of safety, effectiveness and value to satisfy not only regulatory stakeholders but also payers, clinicians, and patients.

In this webinar, our speakers will cover:

  • Regulatory pathways and legislation in the US and EU
  • Stakeholders and uptake considerations
  • Methodological considerations for generating high-quality real-world evidence
  • Q&A