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Text: A biologic is a type of drug derived from natural, biological sources such as animals or microorganisms. Biologics thus differ from traditional drugs, which are typically synthesized from chemicals.1 A manufacturer of a biologic may market the drug only if the FDA has licensed it pursuant to either of two review processes set forth in §262. The default pathway for approval, used for new biologics, is set forth in §262(a). Under that subsection, the FDA may license a new biologic if, among other things, the manufacturer demonstrates that it is “safe, pure, and potent.” §262(a)(2)(C)(i)(I). In addition to this default route, the statute also prescribes an alternative, abbreviated route for FDA approval of biosimilars, which is set forth in §262(k).

To obtain approval through the BPCIA’s abbreviated process, the manufacturer of a biosimilar (applicant) does not need to show that the product is “safe, pure, and potent.” Instead, the applicant may piggyback on the showing made by the manufacturer (sponsor) of a previously licensed biologic (reference product). See §262(k)(2)(A)(iii). An applicant must show that its product is “highly similar” to the reference product and that there are no “clinically meaningful differences” between the two in terms of “safety, purity, and potency.” §§262(i)(2)(A), (B); see also §262(k)(2)(A)(i)(I). An applicant may not submit an application until 4 years after the reference product is first licensed, and the FDA may not license a biosimilar until 12 years after the reference product is first licensed. §§262(k)(7)(A), (B). As a result, the manufacturer of a new biologic enjoys a 12-year period when its biologic may be marketed without competition from biosimilars.