What Does the Law Say?
To regulate this emerging field of science, the United States Congress established a new framework for scientists and manufacturers seeking approval to make new biosimilar therapies available to patients. As part of the landmark Patient Protection and Affordable Care Act (ACA) of 2010, the Biologics Price Competition and Innovation Act (BPCIA) lays out requirements for the approval of biosimilars and interchangeable biologic products and assigned FDA the task of designing the detailed approval pathway for these medicines.
The BPCIA requires that a biosimilar must demonstrate no clinically meaningful difference from its reference biologic in terms of safety and quality metrics like purity and potency. This means patients and health care professionals can rely upon the fact that a biosimilar medicine or interchangeable biologic will treat the same disease as safely and effectively as the original brand product. It is important to understand that the interchangeability designation does not represent a “higher” standard than for a biosimilar product, but rather adds the requirement for additional scientific data related to multiple switches between products. Per the law, a biosimilar must meet safety, efficacy and quality requirements and can be used for all approved indications of the reference product. (see Appendix for the full text of the law).