Expedited Access to Biosimilars Act

The Expedited Access to Biosimilars Act modifies federal regulations to streamline the approval process for biosimilar drugs, which are lower-cost versions of existing biologic medicines. The bill requires manufacturers to conduct specific studies on how the drug behaves in the body and how the immune system reacts to it, while limiting the need for additional large-scale clinical trials unless the FDA explicitly determines they are necessary. To ensure transparency, the law mandates that the FDA must provide written notice to drug sponsors within 60 days regarding whether extra studies are required. These changes aim to reduce the time and cost involved in bringing biosimilars to market, potentially increasing patient access to affordable treatment options.