Table 1.

Food and Drug Administration pathways available for the approval of biosimilar drugs

ActUnited States Drug Approval Statutes
Food Drug and Cosmetic Act
 505(b)(1) NDAFull stand-alone NDA. Approval process typically used for new chemical entities. Sponsor-produced preclinical and clinical data are used to support approval.
 505(b)(2) NDAAbbreviated licensure pathway. Allows sponsor to rely partially on existing publically available pharmacology, safety, and efficacy data on molecule. Typically, the approval process for a new dosage form, new indication, or new delivery system. Process established by Hatch–Waxman Act of 1984.
 505(j) ANDA for generic agentsAbbreviated application for generic drugs. Identical active ingredient, dosage, form, and route of administration as reference licensed drug. Sponsor shows PK bioequivalence to reference product in healthy subjects. Application references safety and efficacy data from licensed drug. Process established by Hatch–Waxman Act of 1984.
Public Health Services Act
 351(a) BLAFull standalone application for biologic drugs. Sponsor-generated data from preclinical and clinical programs are used to support approval.
 351(k) BLA for biosimilar agentsAbbreviated licensure pathway for follow-on biologic products shown to be highly similar to an FDA-licensed reference biologic. Extensive analytical testing and tailored clinical comparison with reference biologic are needed to support approval. Process established by the Biologic Price Competition and Innovation Act of 2009.
  • NDA, new drug application; ANDA, abbreviated new drug application; BLA, biologics license application; PK, pharmacokinetics; FDA, Food and Drug Administration.