Biosimilars

Curated by Anthony H. Nguyen, J.D.
Sr. Writer and Analyst

Biosimilars, also referred to as follow-on biologics, are biopharmaceutical drugs designed to be similar but not identical copies of a known biological reference product and have been shown to have no clinically meaningful differences from the previously licensed reference biologic. The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was enacted with the passage of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148). Section 7002 of the ACA required the FDA to develop an expedited process for the approval of biosimilars, modeled after the abbreviated pathway used for the approval of generic small-molecule drugs, when the agency finds that standards for safety, risk mitigation, and clinical effectiveness have been met.