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Biobetters pp 361-370 | Cite as

Building Biobetters: The Regulatory Landscape

  • Emanuela Lacana
  • Lynne Yao
  • Anne Pariser
  • Amy Rosenberg
  • Janet Woodcock
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 19)

Abstract

Whether new versions of currently marketed, or de novo biological drugs, biobetters are products specifically designed to maximize clinical performance. Performance optimization may include, among other improvements, enhanced targeting and delivery, increased activity and half-life, and reduced immunogenicity. Thus, it is critical that such products are developed efficiently and quickly, to allow patients access to drugs that provide maximum clinical benefits.

Over the past 30 years, legislative mandates provided FDA with the flexibility to offer incentive programs and define novel regulatory pathways to aid in drug development, particularly for drugs to treat serious or life threatening diseases or unmet medical needs. These programs have been crucial for the approval of, for example, antiviral therapies for AIDS, or orphan drugs to treat rare diseases. This chapter outlines the salient features of several expedited regulatory pathways and selected incentive programs, provides examples of “biobettering” strategies and describes how expedited regulatory pathways and incentive program may be applied to the development of biobetter drugs.

Keywords

Fabry Disease Incentive Program Fast Track Pompe Disease Federal Food 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© American Association of Pharmaceutical Scientists 2015

Authors and Affiliations

  • Emanuela Lacana
    • 1
  • Lynne Yao
    • 3
  • Anne Pariser
    • 4
  • Amy Rosenberg
    • 2
  • Janet Woodcock
    • 5
  1. 1.Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug AdministrationSilver SpringUSA
  2. 2.Division of Biotechnology Review and Research IIIOffice of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug AdministrationSilver SpringUSA
  3. 3.Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug AdministrationSilver SpringUSA
  4. 4.Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug AdministrationSilver SpringUSA
  5. 5.Center for Drug Evaluation and Research, Food and Drug AdministrationSilver SpringUSA

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