The "Ensuring Timely Access to Generics Act of 2025" aims to amend the Federal Food, Drug, and Cosmetic Act, specifically Section 505(q), to address the issue of citizen petitions being used to impede the timely approval of generic drugs and biosimilars. This legislation seeks to streamline the regulatory process by providing clearer guidelines for the Food and Drug Administration (FDA) in evaluating such petitions. A significant provision outlines new criteria for the Secretary to determine if a petition's primary purpose is to delay an application. These factors include the timeliness of the petition's submission relative to when the petitioner knew the relevant information, whether it was submitted close to a known approval date for a generic or biosimilar, and if the petitioner has a history of submitting multiple or serial petitions raising previously known issues. The FDA may also consider if the petition lacks relevant data, raises already-addressed issues, or requests more onerous standards than applicable. The bill mandates that a person must submit a citizen petition to the Secretary and exhaust administrative remedies before filing a civil action to delay or prevent the approval of a generic or biosimilar application. Furthermore, petitions and any supplements must be submitted within 180 days after the petitioner knew the information forming the basis of the request. Failure to comply with these requirements will result in the dismissal of the civil action, either without prejudice for not exhausting administrative remedies or with prejudice for untimely filing.