Expedited Access to Biosimilars Act

This bill changes the rules for getting approval of biosimilar products, which are alternatives to brand-name biological drugs and vaccines. Right now, companies that want to sell a biosimilar usually have to conduct a clinical study showing it is safe and effective, but this bill removes that requirement unless the FDA decides the study is needed. If the FDA does require such a study, it must explain why in writing within a set time frame. The bill also removes a rule that says the same FDA team that reviewed the original brand-name product has to be the one to review the biosimilar application.

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