; and (II) if the Secretary finds that such product meets such criteria, designate the biosimilar biological product as a competitive biosimilar therapy. (C) Actions In expediting the development and review of an application under subparagraph (A), the Secretary may, as requested by the applicant, take actions including the following: (i) Hold meetings with the sponsor and the review team throughout the development of the biosimilar biological product prior to submission of the application under this subsection. (ii) Provide timely advice to, and interactive communication with, the sponsor regarding the development of the drug to ensure that the development program to gather the data necessary for approval is as efficient as practicable. (iii) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to biological product-device combination products and other complex products. (iv) Assign a cross-disciplinary project lead— (I) to facilitate an efficient review of the development program and application, including manufacturing inspections