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The Expedited Access to Biosimilars Act would streamline the approval process for biosimilar drugs by changing FDA requirements for clinical studies. Currently, biosimilars must demonstrate they work similarly to the original drug through extensive clinical testing that may include studies on how the drug works in the body and its effectiveness. This bill would make it the default expectation that manufacturers do not need to conduct these types of efficacy and pharmacodynamics studies unless the FDA specifically determines they are necessary and provides written notice to the drug maker. The FDA would be required to communicate this determination to manufacturers either during an early development meeting or within 60 days of receiving an application. The changes would apply to any biosimilar applications submitted after the bill becomes law and are intended to speed up the path to market for these lower-cost alternatives to expensive biologic drugs.

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