definiens: means, with respect to a particular Licensed Product ina particular country, a biologic product that is ( a ) substantially similar to or interchangeable with suchLicensed Product, such that the application for a BLA for such biologic product submitted to the applicableRegulatory Authority relies in whole or in part on a prior BLA granted to such Licensed Product ( includingany application for such biological product submitted under Section 351(k ) of the PHSA or successor law, or other analogous Applicable Law, citing the Licensed Product as the reference product ), or ( b)determined by the applicable Regulatory Authority to be interchangeable with such Licensed Product, asset forth at 42 U.S.C. § 262(k)(4 ) or successor law, or other analogous Applicable Law outside of theUnited States . A biological product licensed under the same BLA as the Licensed Product will notconstitute a Biosimilar Product