CRS – Follow-On Biologics: The Law and Intellectual Property Issues

by Sabrina I. Pacifici on January 22, 2013

Follow-On Biologics: The Law and Intellectual Property Issues, Wendy H. Schacht, Specialist in Science and Technology Policy; John R. Thomas, Visiting Scholar, December 6, 2012

  • “The term “biologics” refers to a category of medical preparations derived from a living organism. These medicines have added notable therapeutic options for many diseases and impacted fields such as oncology and rheumatology. The biologics industry invests extensively in R&D and contributes to a rapidly expanding market for these treatments. Biologics are often costly, however, in part due to the sophistication of the technologies and the manufacturing techniques needed to make them. Some commentators have also observed that, in contrast to the generic drugs available in traditional pharmaceutical markets, few “follow-on” biologics compete with the original, brandname product. The lack of competition in the biologics markets is perceived to be a consequence of the complexity of biologics in comparison with small-molecule, chemical-based pharmaceuticals. As a result, previously existing accelerated marketing provisions for traditional generic drugs provided under the Federal Food, Drug, and Cosmetic Act do not comfortably apply to biologics.”
  • Posted in Legal Research

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