definiens: means, with respect to a particular Product or Combination Product and a particular country, ( i ) any pharmaceutical product ( other than the Product or Combination Product, as applicable ) that contains the same active ingredient(s ) in a comp arable quality and quantity as such Product or Combination Product, as applicable, irrespective of its pharmaceutical form and is approved under an Abbreviated New Drug Application ( ANDA ) or under 505(b)(2 ) of the United States Federal Food, Drug and Cosme tic Act or any similar abbreviated route of approval in such country, or ( ii ) any biologic medicinal product ( other than the Product or Combination Product, as applicable ) that is a biosimilar product of such Product, and, if the Product is a component of a Combination Product, a biosimilar product of the Combination Product, and is approved under a Biological Product Licensure application submitted by any person under 42 U.S.C. § 262(k ) or any similar abbreviated route of approval in such country