As used in this chapter, "biosimilar" refers to a biological product that:

1. (1) has been licensed as a biosimilar product under 41 U.S.C. 262(k) or has been approved based on an application filed under 21 U.S.C. 355(b)(2); and

2. (2) is highly similar to the reference product, with:

   1. (A) no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency of the product; and
   2. (B) only minor differences in clinically inactive components.

As added by P.L.96-2014, SEC.6.