Biological products are the fastest growing class of therapeutic products in the United States and account for a substantial and increasing portion of health care costs. Congress, through the Biologics Price Competition and Innovation Act (BPCI) of 2009, created an abbreviated approval pathway as a way to provide the public with greater access to biological products that are effective and safe. This pathway was established as a way to provide more treatment options by increasing access to lifesaving medications and potentially lowering health care costs through competition.
- Guidance for Industry
- Biosimilar User Fees
- Biosimilars Action Plan
- Educational Resources
Implementation of the Biologics Price Competition and Innovation Act of 2009
Overview of the BPCI Act and the Biosimilar Implementation Committee, a cross-center group led by Drs. Janet Woodcock and Karen Midthun.
Congressional Testimony: Biosimilars Implementation
Congressional testimony from Dr. Janet Woodcock discussing FDA’s implementation of the BPCI Act.
Senate Testimony: Biosimilar Implementation: A Progress Report from FDA
Senate testimony from Dr. Janet Woodcock discussing FDA’s implementation of the BPCI Act.
Congressional Testimony: Generic Drug User Fee Act Reauthorization (GDUFA II), Biosimilar User Fee Act Reauthorization (BsUFA II)
Congressional testimony from Dr. Janet Woodcock discussing the first reauthorization of GDUFA II, as well as the first reauthorization of BsUFA II.
Sections 7001-7003 (Biologics Price Competition and Innovation Act of 2009) of the Patient Protection and Affordable Care Act (Public Law No. 111-148)
Official language of the BPCI Act.