This bill amends the Public Health Service Act to change the FDA approval process for biosimilar biological products, which are near-identical, lower-cost versions of brand-name biologic drugs. Under current law, biosimilar applicants often must conduct extensive clinical studies, including comparative efficacy trials, to prove their product works the same as the original. The bill limits when the FDA can require these additional studies, allowing the agency to mandate assessments of immunogenicity, pharmacodynamics, or comparative efficacy only when it provides written justification to the applicant early in the process, generally by the time of biosimilar development meetings or within 60 days of application submission. It also restricts the FDA's ability to later change these requirements unless there is mutual agreement or a documented scientific justification, with an option for the applicant to request a follow-up meeting. This is intended to speed up biosimilar approvals and reduce development costs, ultimately affecting drug manufacturers seeking to bring biosimilars to market and potentially increasing competition and affordability for patients. The changes would apply to biosimilar applications submitted on or after the law's enactment.
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