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Streamline regulations for biosimilars. The Biologics Worth Competitors and Innovation Act of 2009 takes a cautious and costly stance by requiring biosimilar producers to undertake phase III medical trials to prove that their medication are as protected and efficient as their branded equivalents. Furthermore, the BPCI act awards biologic medicine 12 years of market exclusivity no matter their underlying intellectual property, in comparison with 5 years for small molecules. It's troublesome to justify a seven-year distinction between mandatory exclusivity intervals for biologics vs. small molecules.
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