definiens: means, with respect to a particu lar Product or Combination Product and a particular country, ( a ) a ny pharmaceutical product ( other than the Product or Combination Product, as applicable ) that contains the same active ingredient(s ) in a comparable quality and quantity as such Product or Combination Product, as applicable, irrespective of its pharmac eutical form and is approved under an Abbreviated New Drug Application or under 505(b)(2 ) of the United States Federal Food, Drug and Cosmetic Act or any similar abbreviated ro ute of approval in such country, or ( b ) any biologic medicinal product ( other than the Product or Combination Product, as applicable ) that is a Biosimilar Product of such Pr oduct, and, if the Product is a component of a Combination Product, a Biosimilar Product of t he Combination Product, and is approved under a Biological Product Licensure appli cation submitted by any person under 42 U.S.C. § 262(k ) or any similar abbreviated route of approval in such country