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Tag: FDA exclusivity

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

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. This delay, enforced by law and patent strategies, keeps prices high and limits patient access. Here's how the system works-and why it's changing.

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