Information for Healthcare Professionals (Biosimilars)
The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. These new statutory provisions also may be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
- Biosimilarity means that the biological product is highly similar to the U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components; and that there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity, and potency of the product.
- Interchangeability means that the biologic product is biosimilar to the U.S.-licensed reference biological product and can be expected to produce the same clinical result as the reference product in any given patient. For a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product will not be greater than the risk of using the reference product without such alternation or switch. Interchangeable biological products may be substituted at the pharmacy level without the intervention of a healthcare provider.
Resources will be posted in this section as they become available to answer drug-related questions.
Approval Pathway for Biosimilar and Interchangeable Biological Products Public Meeting[ARCHIVED] Implementation of the Biologics Price Competition and Innovation Act of 2009 Sections 7001-7003 (Biologics Price Competition and Innovation Act of 2009) of the Patient Protection and Affordable Care Act (Public Law No. 111-148)(PDF - 122KB)