Biosimilars for Rheumatoid Arthritis in the US - a year on

In the US, there are approximately 1.3 million adults living with rheumatoid arthritis (RA), representing 0.6 to 1% of the adult population. Biologic medicines have been shown to be effective treatment options for this condition, reducing inflammation, relieving pain, preventing and slowing down joint damage, reducing disability, and enabling those with the condition to be as active as possible. However, management of a chronic condition like RA and regular biologic treatments have their price; the total annual health cost for treatment is estimated to be around USD 19.3 billion.1

2023 marked a watershed moment for patients with RA in the US; the launch of the first biosimilar for the leading RA reference biologic. With 2022 sales of the leading reference biologic reaching USD 21.2 billion2, the market entry of biosimilar options represented the largest loss of exclusivity in pharmaceutical history. 

For people living with RA in the US, biosimilar options have been long-awaited, with biosimilars first becoming available in Europe in 2017. A year on since the first RA biosimilar launched in the US, eight others have already entered the market. With multiple biosimilar options now available, the hope is that increased adoption of biosimilars will lead to reduced healthcare costs and provide additional treatment options for patients. 

Biosimilars for Rheumatoid Arthritis in the US - a year on

Challenges of bringing biosimilars to patients remain

Despite the availability of multiple biosimilars for the treatment of RA in the US, access to biosimilar options vary.  Access challenges are often rooted in policies of American healthcare coverage and insurance programs, as well as their complexities and the time it can take to adopt change. 

The Office of Inspector General reported that Medicare alone has the potential to save USD 84 million each year if biosimilars were made readily available and placed favorably on formularies.3  However, a January 2024 Medicare Part D status report revealed that approximately 40% of Medicare beneficiaries still don’t have access to biosimilars on their formulary.4 

While some patients in integrated health systems are able to access these biosimilars faster, over the past year, many others have been required to take the reference product before being considered for a biosimilar. This not only removes the choice for patients and their doctors to start with a biosimilar, but also blocks the potential savings that biosimilars offer. However, I am excited to see that progress is being made this year, with at least one major Pharmacy Benefit Manager (PBM) updating its formula to prefer biosimilars over the reference medicine. 

The Act4Biosimilars Deep Dive Report for the Americas region highlights the need for streamlined access to biosimilars in the US. Now is the time to review policies and for healthcare systems to unlock the full potential of biosimilars, ensuring patients can access life-changing and potentially life-saving medicines.

All stakeholders, including payers, healthcare professionals, and pharmacists, must play a role in ensuring patients are comfortable and confident during biosimilar transitions

The importance of involving and supporting patients in the transition to biosimilars

Another challenge is ensuring biosimilars are introduced with a patient-focused approach.  

As part of my work at the Arthritis Foundation, in 2022 we conducted a survey and subsequent focus groups which showed patients have concerns about clinical efficacy and potential adverse events of biosimilar treatment options. There are also concerns among patients about transitioning when they are currently stable on the reference product, even if they know there are no clinically meaningful differences. A further focus group conducted in 2023 also highlighted that some patients are not experiencing a seamless transition and are being left with questions ranging from what the biosimilar is, to how the injection device works. Forcing a transition without appropriate education, communication and shared decision-making will not yield a positive outcome. 

As outlined in the Act4Biosimilars Action Plan – the roadmap to improve the Approvability, Accessibility, Acceptability and Affordability of biosimilar medicines, all stakeholders, including payers, healthcare professionals, and pharmacists, must play a role in ensuring patients are comfortable and confident during biosimilar transitions. This aligns with my work at the Arthritis Foundation, where we have developed best practices for patient communications, tailored to each of these stakeholders, and we encourage their use as part of their communications processes. These resources, in addition to many other materials such as webinar recordings and FAQs, can be found on the Arthritis Foundation’s website at We support increased adoption of biosimilars which is linked to patient-focused strategies that prioritize patient confidence.  

The launch of biosimilars for RA in the US is a positive step forward to enabling affordable access to biologic medicines. With streamlined pathways and better patient support, I am excited to see how biosimilars can make an impact on patients, healthcare systems, and society.

Anna Hyde

Vice President of Advocacy and Access
Arthritis Foundation

Anna Hyde
  1. Cross, Marita, et al. “The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study.” Annals of the rheumatic diseases, 73(7), 1316-1322. 2014.
  2. AbbVie. “AbbVie Reports Full-Year and Fourth-Quarter 2022 Financial Results”. 2023. Available from:
  3. Murrin, Suzanne. “Medicare Part D and Beneficiaries Could Realize Significant Spending Reductions With Increased Biosimilar Use”. Office of Inspector General. 2022.  Available from:
  4. Hayes, Tara and Shinobu Suzuki. “Medicare Prescription Drug Program (Part D): Status Report.” 2024. Available from: MedPAC-Part-D-status-report-Jan-2024.pdf