Amgen US Biosimilars Policy

Experience that can’t be replicated

When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, creating the biosimilars approval pathway, Amgen embraced the opportunity to extend our mission to serve patients. We recognized that biosimilars would become an important part of broadening patient and physician options for biologic treatments and foresaw that our expertise in developing and manufacturing biologics also would apply to biosimilars.

Today, we remain fully committed to the success of the biosimilars market and to our portfolio of 10 biosimilars in development (two of which already have received FDA approval)*, which target serious diseases. Amgen is unique in the biosimilars space in that we have a 40-year heritage of discovering and developing novel biologic medicines. This experience gives us valuable insight into what is needed for biosimilars and originator biologics to succeed for patients, physicians, and payers.

*As of December 31, 2018.

Building a robust and sustainable market through science-based policies

To achieve the promised savings in the US health care system from biosimilars, we need to advance science-based policies that instill physician and patient confidence, create a level playing field for reimbursement, and foster biosimilar competition.

Amgen believes that to create and grow a robust and sustainable biosimilars marketplace over the long term:

  • Regulators must maintain scientifically appropriate development standards for biosimilarity and interchangeability that will instill physician and patient confidence, while ensuring patient safety and efficacy
  • Robust competition on a level playing field must be established with respect to reimbursement to achieve lower costs in a manner that builds stability over the long term
  • Policies must support both innovation in biological products and widespread acceptance of biosimilars
  • Science-based education for stakeholders is needed to promote uptake and proper use

Biosimilar Resources

General resources:

Biologics prescribers collaborative:

National conference of state legislatures:

Amgen in the News

Note: a subscription may be required for some of the following links:

Previous: media releases

Next: BioEngage