ACI's 6th Annual Summit on Biosimilars

The Definitive Forum on the Legal, Regulatory, Patent, and Commercial Realities of Follow-On Biologics

June 2, 2015

New York, NY

Senior counsel Brian Malkin spoke on the topic "Protecting Both Innovation and Competition: Finding Compromise Within Federal and State Biosimilars Substitution Laws," at this event hosted by the American Conference Institute.

Discussion topics include:

  • Examining the role and responsibility of the US Federal Trade Commission (FTC) in protecting competition in the biosimilars space
  • Overview of the open questions left after the 2014 FTC hearing on biosimilars and comments received by industry
  • Recapping the relevant Citizen’s Petitions filed by industry in this area
  • Analyzing the interplay between federal biosimilars laws and state law issues including notification, attributing adverse events, and applying interchangeability on the pharmacy level
  • Breakdown of state laws regarding interchangeable biosimilar substitution: which states have weighed in to date?
    • What should be required for notification?
    • Record keeping: to what level should pharmacists be required to keep records?
    • Responding to alleged anti-competitive effect of notification provisions
    • Keeping the goal of patient safety and knowledge first and foremost
  • Weighing in on the continued debate and controversy in the biosimilars naming process (main bullet)
    • Update on FDA guidance and working groups on policies for nonproprietary naming, science, and interchangeability
    • Understanding the distinction from the International Nonproprietary Naming (INN) system, administered by WHO
    • Overview of the multiple Citizen’s Petitions filed and related docket comments regarding naming
    • Discussing the benefits and drawbacks of using a distinct nonproprietary name or a brand / trade name to distinguish biosimilars from reference products
    • Exploring whether the use of a distinct nonproprietary name will affect biosimilars market uptake
    • How distinct will the biosimilar product name have to be from the original in order to facilitate traceability?
    • Relationship between naming and product labeling under current pharmacovigilance practices in the US

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