definiens: means, with respect to a product, a biological medicinal product or biological product for human usewhich : ( a ) is highly similar to such product notwithstanding minor diﬀerences in clinically inactive components ; ( b ) has noclinically meaningful differences with regard to such product in terms of safety, purity, or potency, as determined by ApplicableLaw or any applicable Regulatory Authority ; and ( c ) is approved for use ( i ) in the U.S., under 42 U.S.C § 262(k ) as a biosimilarbiological product ( as deﬁned in 42 U.S.C. § 262(i)(1 ), ( 2 ) ) and for which such product is the reference product ( as deﬁned in42 U.S.C. § 262(i)(4 ) ) or ( ii ) in any other country or jurisdiction, pursuant to an equivalent regime in such country orjurisdiction, and for which such product is the reference product