There are 29 biosimilars approved in the US, almost two thirds of which have launched on the market [1]. However, there remains significant barriers to biosimilar uptake in the US, including payment policies that disincentivize the use of biosimilars, anti-competitive business strategies, and a lack of understanding among patients and healthcare professionals [2].

To address this last point, in April 2021 President Biden signed the Advancing Education on Biosimilars Act of 2021, which authorizes FDA to educate patients and healthcare providers on the benefits of biosimilars.

The Biosimilars Council, a division of the Association for Accessible Medicines which focuses on improving access to biosimilar medicines, welcomed the news. Executive Director Christine Simmon commented: ‘Education is a crucial step toward more widespread adoption of safe, effective and more-affordable biosimilar therapies. There is much work to be done in the United States to increase usage of biosimilars, stimulate competition and reduce prices for patients, and we look forward to working with our counterparts at the Food and Drug Administration to inform providers and patients about the benefits that biosimilars bring to the market’.

Other efforts to improve biosimilar access include the reintroduction of the BIOSIM Act on April 23, 2021. This bipartisan Act provides for increased reimbursement to hospitals and physicians for biosimilar drugs for a period of five years. Specifically, the Act will increase biosimilar reimbursement in Medicare Part B (under which providers receive reimbursement for dispensing based on the average sales price [ASP] of the drug) to the ASP of the drug plus 8%.

Christine Simmon also supported this news, saying: ‘By modestly boosting reimbursement to healthcare providers using biosimilars, the BIOSIM Act will encourage faster adoption of these novel treatments and deliver savings for providers and patients’.

Other ways to increase the use of biosimilars in the US were suggested in a new IQVIA report ‘Biosimilars in the US: reimbursement and impacts to uptake’, published in March 2021. The report shows that biosimilars are more likely to be used when relative reimbursement to physicians (the difference between the reimbursement for the product and its acquisition cost) is higher for the biosimilar. It also found that biosimilar adoption was higher for providers in the CMS Oncology Care Model, in which providers are accountable for the total cost of care.

The report suggests that Medicare payment policies should reward the use of biosimilars over more expensive, brand-name biologicals. They suggest, for example, that the Medicare Part B add-on payment be increased for biosimilars. Similarly, the Medicare Part D programme (which helps to cover the cost of prescription drugs) could be updated to encourage health plans to prioritize the use of biosimilars.

Related articles
Approval and launch dates for US biosimilars – 2021

US guidelines for biosimilars

The sluggish US biosimilars market

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US 
2. GaBI Online - Generics and Biosimilars Initiative. US policy brief identifies barriers to biosimilars uptake [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Jun 4]. Available from: www.gabionline.net/Policies-Legislation/US-policy-brief-identifies-barriers-to-biosimilars-uptake

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