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How Biosimilars can contribute to healthcare system sustainability

Company: AMGEN, s.r.o.

Biosimilars can help establish a path to a more resilient future


At Amgen, we believe that high-quality biosimilars, coupled with robust competition, provide patients with needed treatment options, help contain costs and contribute to long-term health care system resilience. This is all the more important as our leaders take stock of the impact the pandemic has had on the management of disease and consider ways to build a health care system that is more resilient to this level of disruption.  

We know biosimilars are helping patients today and will help strengthen the U.S. health care system in the long term. Since 2015, 34 biosimilars have been approved by the U.S. Food and Drug Administration (FDA) and 21 are available in the U.S. (1,2) This momentum has resulted in patients seeing more treatment options and lower costs. We also know that biosimilars have contributed to a $9.8 billion cumulative reduction in drug spend for classes with biosimilar competition over the past five years. (3,4) Given these trends, by some estimates, biosimilars are expected to save the U.S. health care system approximately $150 billion over the next 5-10 years – savings that can be applied to other much needed areas. (5)  

As we’re seeing the second wave of biosimilars coming to market, we’re also at an important inflection point. Federal policymakers are currently considering the reauthorization of the biosimilar user fee agreement (BsUFA), a critical piece of legislation designed to support the review of biosimilars, and its timely reauthorization is critical for continued success of the biosimilars review program. Beyond BsUFA, policymakers play an important role in supporting and advancing biosimilars. Policymakers can best nurture a long-term, sustainable marketplace with biosimilars by:  

  • Continuing to foster head-to-head competition among reference products and between biosimilars without reimbursement advantages that artificially tip the scales or destabilize the market; 
  • Supporting awareness and education about biologics, including biosimilars, at every level – particularly as they are introduced in new therapeutic areas and some gain interchangeability designations; and  
  • Investing in innovation and technology to help guard against future pandemics and other unforeseen events. 

Competition created by reliably supplied, high-quality biosimilars has the potential to alleviate some of the financial burden for governments, hospitals and patients, while delivering the clinical benefits of biologic medicines. This can set our health systems on the path to a more resilient future. 


  1. Xcenda. Biosimilar Approval and Launch Status in US. https://www.xcenda.com/biosimilars-trends-report. Published July 2021. Accessed November 2021.   
  2. FDA. Biosimilar Product Information. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Published September 20, 2021. Accessed November 2021.  
  3. Amgen. 2021 Biosimilar Trends Report. “US Biosimilar Approvals and Launches 7-Year Trend.” Page 12. 
  4. Amgen. 2021 Biosimilar Trends Report. “Biosimilar Competition Appears to be Contributing to Decreased Drug Spending.” Page 15. 
  5. The Center For Biosimilars. “Biosimilars market is ripe for cost savings.” June 27, 2019. www.centerforbiosimilars.com/contributor/chad-pettit/2019/06/biosimilars-market-is-ripe-for-cost-savings.  


Ian Thompson

Senior Vice President, General Manager, US Business Operations at Amgen



Tags: Health | Sustainability |

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