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Tag: FDA exclusivity

Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market
Medical Research and Development
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Biologic Patent Protection: When Biosimilars Can Enter the U.S. Market

December 26, 2025 by Maxwell Harrington

Biologic patent protection in the U.S. grants 12 years of exclusivity before biosimilars can enter the market. Complex regulations, patent thickets, and high development costs delay competition, keeping prices high and patients paying more than they should.

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