Amgen US Biosimilars Policy | Amgen Biosimilars

Amgen US Biosimilars Policy Positions

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 healthcare marketplace with biosimilars, and to our portfolio of 10 biosimilars in development (four of which already have received FDA approval)* that target serious diseases. Amgen is unique in the biosimilars space in that we have a 40-year heritage of discovering and developing originator 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 August 2021

Building a robust and sustainable market through science-based policies

To achieve the promised savings in the US healthcare system from biosimilars, we need to advance science-based policies that 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:
  • Patient, physician, pharmacist, and payer confidence in biosimilars requires scientifically appropriate regulatory standards
  • Meaningful savings and long-term stability can accrue from a marketplace that encourages head‑to‑head competition—with originator products and between biosimilar products
  • Biosimilars will be promoted by scientifically accurate educational outreach
  • A foundation of intellectual property is a vital component of a successful marketplace