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Tag: BPCIA

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market
  • Dec, 4 2025
  • Comments 15

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

Biologic drugs in the U.S. enjoy 12 years of market exclusivity before biosimilars can enter, thanks to FDA rules and patent thickets. This delays competition, keeps prices high, and leaves patients paying more than those in other countries.
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