This bill would make some extra biosimilar drug studies optional instead of routine. Federal health officials could still require them, but they would have to give the company written reasons early in the process.
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Expedited Access to Biosimilars Act is a Senate bill in committee. The latest recorded action: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Latest action on S. 1414: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Who this affects: This bill mainly affects companies that develop biosimilars and the Food and Drug Administration staff who review them. Patients and health plans could also feel the effects if the change helps more biosimilars reach the market. The bill would apply only to future biosimilar applications filed after it becomes law.
Why this matters: Biosimilars can give patients more choices for costly biologic medicines, and this bill could make some of them easier to bring to market. It may reduce testing costs for drug makers. It may also speed up some applications. The safety tradeoff depends on how often FDA leaders still require extra studies for immune reactions or other important differences.
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