definiens: means, with respect to a particular Product or Co mbination Product and a particular country, ( a ) any pharmaceutical product ( other than the Product or Combination Product, as applicable ) that contains the same acti ve ingredient(s ) in a comparable quality and quantity as such Product or Combination Product, as applicable, irrespective of its pharmaceutical form and is approved under an Abbrev iated New Drug Application or under 505(b)(2 ) of the United States Federal Food . Drug a nd Cosmetic Act or any similar abbreviated route of approval in such country, or ( b ) any biologic medicinal product ( other than the Product or Combination Product, as applica ble ) that is a Biosimilar Product of such Product, and, if the Product is a component of a Co mbination Product, a Biosimilar Product of the Combination Product, and is approved under a Bi ological Product Licensure application submitted by any person under 42 U.S.C. § 262(k ) or any similar abbreviated route of approval in such country