S 1140
Protecting Access to Biosimilars Act of 2019
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Bill overview
The Protecting Access to Biosimilars Act of 2019 aims to speed up the availability of biosimilar drugs in the United States. Currently, certain biological products initially approved under the Food, Drug, and Cosmetic Act receive a period of market exclusivity that delays the approval of biosimilar versions. This bill modifies a key provision of the Public Health Service Act to prevent these initial approvals from granting an extended exclusivity period, allowing biosimilar competitors to enter the market sooner. It effectively reduces the barriers to competition for biosimilar medications.
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