Expedited Access to Biosimilars Act

(cc) an assessment of pharmacokinetics and immunogenicity (which may rely on, or consist of, a clinical pharmacokinetics study or studies or a study or studies described in item (aa) or (dd), as appropriate); and

(dd) subject to clause (iv), an additional clinical study or studies in 1 or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product;

(iv) Limitation on requiring additional clinical study or studies. The Secretary may only require an additional clinical study or studies described in clause (i)(I)(dd), including a study or studies that include an assessment of pharmacodynamics or efficacy, if the Secretary determines that such study or studies are necessary, in combination with the other studies described in clause (i)(I), to demonstrate biosimilarity and provides written notice of such determination to the sponsor of the proposed biosimilar biological product. Such written notice shall be provided not later than—

(I) the date on which the Secretary grants a request for a biosimilar biological product development meeting from such sponsor, unless the Secretary describes in writing why an assessment of the need for such study or studies cannot be made at that time; or

(II) if no request for a biosimilar biological product development meeting is submitted or if the Secretary was unable to make the assessment under subclause (I), the date that is 60 days after the date of the submission of an application under this subsection.