Under which act can a biological product be demonstrated to be "biosimilar"?

The Biological Product Control Innovation (BPCI) Act provides the framework for demonstrating that a biological product is "biosimilar" to an already approved biological reference product. This act was enacted as part of the Affordable Care Act in 2010 and aims to promote the approval of biosimilars, encouraging competition in the biological product market while ensuring the safety and efficacy standards are maintained.

The BPCI Act specifically outlines the process for conducting studies and submitting data to the FDA to establish biosimilarity, which includes proving that the biosimilar product is highly similar to the reference product and sharing the same mechanism of action for its indicated uses. Understanding the provisions of the BPCI Act is essential for navigating the regulatory requirements for biosimilars in the U.S.

Other acts listed do not pertain to the approval process for biosimilar products, indicating their inapplicability in this context.