Data exclusivity is the length of time before a biosimilar can receive approval from the US Food and Drug Administration by relying at least in part on the safety and efficacy data for the pioneer biologic. Data exclusivity is one factor contributing to market exclusivity — the period of time during which a therapy is the only marketed version of that molecule — but not the only determinant. The results of patent litigation, the time spent in development and regulatory review, commercial decisions by competitors, and other factors all contribute to the market exclusivity period. The appropriate length of the data exclusivity period was widely debated before the abbreviated pathway for biosimilars was enacted; indeed, the US Congress considered bills with periods ranging from 5 years to 14 years. An earlier article intended to help inform this debate developed a financial model to evaluate how long a market exclusivity period would be required until a typical pioneer biologic earned a positive investment return2. In this model (see Supplementary information S1 (box) for details), a representative portfolio of pioneer biologics would be expected to 'break-even' (or to recover the average costs of development, manufacturing and promotion, and the cost of capital) in 12.9–16.2 years. Here, we present an analysis incorporating two refinements that have been made to this model that directly address important concerns that were raised during the debate leading up to the enactment of the recent US legislation.

Analysis

Enjoying our latest content?
Log in or create an account to continue

  • Access the most recent journalism from Nature's award-winning team
  • Explore the latest features & opinion covering groundbreaking research
Access through your institution

or

Sign in or create an account
Continue with Google
Continue with ORCiD