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Article
Interests in the Balance: FDA Regulations Under the Biologics Price Competition and Innovation Act
UCLA Journal of Law and Technology (2012)
  • Parker M. Tresemer
Abstract
Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is not enough. Competing follow-on biologics have been slow to enter the market, and the significant costs incurred by companies manufacturing both brand-name and follow-on biologics makes measurable cost reductions unlikely. Because the biologics market remains hostile to follow-on product entry even after the Act’s enactment, the FDA must promulgate regulations to facilitate strong follow-on biologics competition while maintaining incentives for brand name manufacturers to produce innovative biologic products.
Keywords
  • BPCIA,
  • competition,
  • innovation,
  • law,
  • patent,
  • regulation,
  • FDA,
  • biologics,
  • biosimilars
Publication Date
Spring 2012
Citation Information
Parker M. Tresemer. "Interests in the Balance: FDA Regulations Under the Biologics Price Competition and Innovation Act" UCLA Journal of Law and Technology Vol. 16 Iss. 1 (2012)
Available at: http://works.bepress.com/parker_tresemer/1/