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Tag: FDA exclusivity

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market
  • 22 November 2025
  • Nigel Watt

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

Biologic drugs in the U.S. enjoy 12 years of exclusivity before biosimilars can enter. Complex patents, high development costs, and legal delays keep prices high. Here’s how the system works-and why patients pay more than in Europe.

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