Expedited Access to Biosimilars Act

This bill amends the Public Health Service Act to change the default requirements for approving biosimilar biological products, making it so that clinical studies assessing pharmacodynamics (how a drug affects the body) or comparative clinical efficacy (how well it works compared to the original) are not automatically expected for licensure. Instead, such studies can only be required if the Secretary of Health and Human Services determines they are necessary to prove biosimilarity and provides written notice to the sponsor.

Sec. 2, Assessment of pharmacodynamics or efficacy in clinical studies required for licensure of biological products as biosimilar: This section revises the list of required studies for a biosimilar application. It replaces the previous requirement for a clinical study assessing pharmacodynamics or efficacy with a new structure: the default studies are assessments of pharmacokinetics (how the body processes the drug) and immunogenicity (immune response), plus an additional clinical study in one or more appropriate conditions of use. The Secretary may only require a study that includes pharmacodynamics or efficacy if it is necessary to demonstrate biosimilarity, and must provide written notice of that determination to the sponsor by the date of a development meeting or within 60 days of application submission, whichever applies. It also repeals a separate requirement for the Secretary to conduct a review of whether such studies are needed.