Hatch-Waxman and BPCIA: Overview of Biosimilars and Life Cycle Planning for Drugs and Biologics

March 11, 2015 1:15pm

1:15 Biosimilars

James Czaban
Wiley Rein LLP (Washington, DC)

  • Overview of Title VII of the Patient Protection and Affordable Care Act (PPACA, P.L. 111-148), i.e., Biologics
    Price Competition and Innovation Act of 2009 (BPCIA)
  • Biosimilar pathway vs. 505(b)(2) and BLAs
  • Defining “biological” and “biosimilars” under BPCIA B Post-Approval Marketing Guidance and Preemption Protocols
  • Exploring interchangeability requirements
  • Understanding the significance of the methods of making claims in this legislation
  • Examining the effect of this abbreviated approval pathway on innovation
  • A look at FDA Rule making and guidance relative to biosimilars
  • How will biosimilars fit in with life cycle strategies?
    • targeting R&D efforts
    • re-examining prosecution efforts
    • anticipating vulnerable patents and litigation

2:30 Bioequivalence and the “Same Active Ingredient” vis-à-vis Patentability

Clark G. Sullivan
Troutman Sanders (New York, NY)

  • Small molecule patent strategies and their application to biologics (e.g., active ingredient claims, purity claims, formulation claims, method claims, etc.)
  • Extra hurdles for patenting biologics (enablement, written description, subject matter eligibility)
  • Bioequivalence v. biosimilarity
  • What lessons can be applied to biologics from FDA’s rating precedent for 505(b)(2) products?
  • What lessons can be applied to biologics from FDA’s same labeling precedent for small molecules?

3:30 Afternoon Refreshment Break

3:45 Marketing Exclusivities (Non-Patent): Challenges, Opportunities, and Current Controversies

David Adams
Venable LLP (Washington, DC)

There are a number of different modes and methods of exclusivity (non-patent). This session will outline what they are and what
challenges, opportunities, and current controversies arise in relation to them, including the role that the FDA plays in regulating these modes of exclusivity. Modes and methods of exclusivity to be discussed include:

  • Orphan Drug Exclusivity (7 years)
  • New Chemical Entity Exclusivity (5 years)
  • New Clinical Study Exclusivity (3 years)
  • Pediatric Exclusivity (6 months)
  • First Generic Applicant Exclusivity (180 days)
  • New Antibiotic Exclusivity

5:00 Master Class B Concludes