Section 1 Short title
This Act may be cited as the “Lowering Costs by Improving Biosimilar Uptake Act”.
Lowering Costs by Improving Biosimilar Uptake Act
A BILL
To amend title III of the Public Health Service Act with respect to the determination by the Secretary regarding certain biosimilar application elements, and for other purposes.
Sec. 2 Determination by Secretary regarding certain biosimilar application elements
Section 351(k)(2)(A)(ii) of the Public Health Service Act (262(k)(2)(A)(ii)) is amended to read as follows:
“(ii) Determination by secretary regarding certain application elements
“(I) In general—The Secretary may determine, in the Secretary’s discretion, that an element described in clause (i)(I), or in clause (i)(IV) with respect to the strength of a biological product, is unnecessary in an application submitted under this subsection.
“(II) Use of determination—If the Secretary makes a determination under this clause that information demonstrating that the strength of the biological product is the same as that of the reference product as described in clause (i)(IV) is unnecessary, the term reference product shall, for purposes of this section with respect to such biological product, include all applicable strengths of the reference product.”