Advancing Education on Biosimilars Act of 2021

The Advancing Education on Biosimilars Act of 2021 became Public Law No: 117-8 on April 23, 2021. This law directs the Secretary of Health and Human Services (HHS) to conduct a public awareness campaign to educate patients, providers, and other stakeholders about biosimilar and interchangeable biological products. This campaign directly addresses the historical lack of understanding and adoption of biosimilars, which has limited their market penetration despite their lower cost and comparable efficacy to branded biologics. The law mandates the dissemination of educational materials, which will increase prescriber confidence and patient acceptance, driving higher utilization rates for biosimilar products. The money trail for this initiative flows through the Department of Health and Human Services (HHS), specifically the Food and Drug Administration (FDA), which is responsible for approving and regulating biosimilars. While the bill does not appropriate a specific dollar amount for the campaign, it mandates its execution, implying a reallocation of existing FDA budget or future appropriations to support these educational efforts. The primary beneficiaries are companies with approved biosimilar products, as increased education directly translates to higher prescription rates and market share. This mechanism is through increased demand for their products, rather than direct grants or contracts. Historically, the biosimilar market has faced significant headwinds due to physician and patient unfamiliarity. For example, despite the FDA approving the first biosimilar in 2015, market penetration remained low for several years. When the Affordable Care Act (ACA) established a pathway for biosimilar approval in 2010, it laid the groundwork, but adoption was slow. The Biosimilar User Fee Amendments (BsUFA) in 2012 and 2017 streamlined the approval process, but education remained a gap. This bill directly addresses that gap. While there isn't a direct historical precedent for a standalone biosimilar education bill and its immediate market reaction, increased clarity and support for biosimilars have consistently benefited manufacturers. For instance, when Amgen's ($AMGN) biosimilar Amjevita launched in early 2023, it faced an uphill battle against Humira. This bill provides a tailwind for such launches by increasing general market acceptance. Specific winners include companies with robust biosimilar pipelines and approved products. Amgen ($AMGN) is a significant player with multiple approved biosimilars. Pfizer ($PFE) has a strong biosimilar portfolio. Sandoz ($SGEN), recently spun off from Novartis, is a pure-play biosimilar company and stands to gain significantly. Viatris ($VTRS), formed from the merger of Mylan ($MYL) and Upjohn, also has a substantial biosimilar presence. Losers are branded biologic manufacturers who will face increased competition and potential market share erosion from biosimilars, though the impact is spread across many large pharmaceutical companies. The timeline for impact is ongoing, as the educational campaign is now mandated and will continue to roll out, steadily increasing biosimilar adoption over the coming years. This legislation solidifies the long-term growth trajectory for the biosimilar market. As education increases, the market share of biosimilars will expand, leading to increased revenue for companies like Amgen ($AMGN), Pfizer ($PFE), Sandoz ($SGEN), and Viatris ($VTRS). This will put sustained competitive pressure on companies relying heavily on branded biologics.