The Biosimilars Forum Statement on the 11-Year Anniversary of the ACA and BPCIA

On the 11-year anniversary of President Obama signing the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the landmark Affordable Care Act (ACA), Biosimilars Forum Executive Director Meaghan Rose Smith issued the following statement:

While the ACA is most heralded for its historic expansion of access to health coverage, the law also contained a critical provision to expand access to lower-cost, life-saving drugs.

The BPCIA paved the way for the Food and Drug Administration (FDA) to approve biosimilars, the second-generation of generics, and create competition that lowers cost for expensive biologics.

In the 11 years since the BPCIA was passed, the FDA has approved nearly 30 biosimilars, with 20 products launched in the U.S. The availability of these biosimilars for U.S. patients is encouraging, but we are far from experiencing the full potential of biosimilars when it comes to savings and access. Biosimilars have the potential to save up to $100 billion over the next five years, but only with increased use by providers and patients.

As we address the financial devastation caused by the COVID-19 pandemic, we encourage the Biden-Harris Administration and Congress to consider policies that will help fully realize the promise of the ACA and BPCIA by increasing patient access to lower-cost biosimilars.

For more information on the Biosimilars Forum or the policy proposals it supports, visit or