Biosimilars and the BPCIA: Exploring Trends, Developments, and Critical Issues


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As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.

Despite the uncertainties, one thing is for sure: biosimilar-related patent litigation will continue to gain momentum. Practitioners and their clients must remain in the loop of recent developments to ensure maximum compliance and improve litigation readiness.

In this LIVE Webcast, a seasoned panel of thought leaders and professionals brought together by The Knowledge Group will provide the audience with an in-depth analysis of the current legal issues surrounding biosimilars and the BPCIA. Speakers will also offer best compliance practices and effective litigation strategies.

  • Biosimilars and the BPCIA – Recent Statistics
  • Recent Regulatory and Litigation Issues
  • Best Compliance Practices
  • Effective Litigation Strategies
  • A Canadian Perspective – Regulatory and Patent Considerations on Biosimilars For Innovator Manufacturers
  • What Lies Ahead