definiens: means, with respect to a particul ar BII Product or Combination Product and a particu lar country, ( a ) any pharmaceutical product ( other than the BII Product or Combination Product, as applicable ) that contains the same active ingredient(s ) in a comparable quali ty and quantity as such BII Product or Combination Product, as applicable irrespective of its pharmaceutical fo rm and is approved under an Abbreviated New Drug Ap plication ( ANDA ) or under 505(b)(2 ) of the United States Fede ral Food, Drug and Cosmetic Act or any similar abbr eviated route of approval in such country, or ( b ) any biolo gic medicinal product ( other than the BII Product o r Combination Product, as applicable ) that is a biosimilar of suc h BII Product, and, if the BII Product is a compone nt of a Combination Product, a biosimilar of the Combinatio n Product, and is approved under a biological produ ct licensure application submitted by any person under 42 U.S.C. § 262(k ) or any similar abbreviated rout e of approval in such country