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Diane Publishing Books
Follow-On Biologics: The Law and Intellectual Property Issues
Wendy H. Schacht (au); John R. Thomas (au)
The term äóģbiologicsäó¯ 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 äóģfollow-onäó¯ biologics compete with the original, brand-name 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 Fed. Food, Drug, and Cosmetic Act do not comfortably apply to biologics. Contents of this report: Introduction; The Biologics Industry; FDA Regulation of Biologics; Marketing Exclusivities and Data Protection; Patent Dispute Resolution; The Potential Market for Follow-On Biologics; Potential Industry Responses; Concluding Observations. This is a print on demand report.
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