As of September 2020, the US Food and Drug Administration (FDA) has approved 28 biosimilars, but only 18 of these medicines are commercially available, primarily due to ongoing litigation or settlements.

In recent decades, science has greatly extended our ability to treat some of the most challenging diseases and conditions, including cancer, and many chronic diseases such as rheumatoid arthritis. At the forefront of these advances are biologics – complex medicines made from living organisms, such as bacteria or yeast.
  
In comparison to many small-molecule medicines, biologics are often challenging to develop and costly to produce. Representing $125.5bn in net drug spending, biologics accounted for less than 2% of all US prescriptions but more than one third of net drug spending in 2018. Between 2012 and 2016, annual spending on biologic drugs in the US nearly doubled, with unit prices accounting for 56% of the spending increase within Medicare Part D and 20% in Part B. As these medicines become more commonplace, and as the US population continues to age and face rising rates of chronic disease, the associated costs will likely continue to rise.

Biosimilars are one of the few proven tools that can help counteract these trends and support healthcare sustainability. After the patent for a biologic has expired, biosimilars can enter the market, and the resulting savings created through increased competition can help healthcare systems reallocate resources to meet additional needs. For example, the biosimilar filgrastim has delivered $1.2bn in savings to the US healthcare system from 2016 to Q1 2020, with Zarxio driving the majority of the market. In total, it is estimated that biosimilars could save the US health system $54bn over ten years.

Moreover, increasing the number of available biosimilars on the US market can improve access to care: an estimated 1.2 million US patients could gain access to biologics by 2025 as the result of increasing biosimilar availability.

Despite their promise, biosimilars have struggled to gain traction in the US, especially when compared to Europe. In fact, Europe accounts for about 90% of worldwide biosimilar sales, while the US is home to more than half of the global biologics market.
As of September 2020, patient out-of-pocket savings lost due to insufficient biosimilar utilisation in the US exceeds $190m and continues to increase each day.

It’s true that health systems differ between countries, but a broader set of barriers has led to lower-than-expected biosimilar adoption in the US. For instance, current reimbursement policies do not incentivise the use of biosimilars within Medicare, and many insurance plans place administrative burdens on physicians by requiring prior authorisation before prescribing a biosimilar – even if the insurer has previously authorised the referenced biologic. Additionally, existing policies restrict the ability of pharmacists to substitute biosimilars for biologics, including FDA regulations around interchangeability, as well as many state laws governing biosimilar substitution. Ongoing patent litigation has slowed biosimilar market entry as well.

These barriers have a real impact for patients and health systems. As of September 2020, the US Food and Drug Administration (FDA) has approved 28 biosimilars, but only 18 of these medicines are commercially available, primarily due to ongoing litigation or settlements. Furthermore, the estimated year-to-date savings lost to the US healthcare system exceeded $21bn between 2018 and 2020.

While challenges remain, in recent years significant progress from major stakeholders, such as the FDA, in addressing the barriers to biosimilar adoption has been encouraging.

To counteract deliberate efforts to foster fear of biosimilars through targeted misinformation campaigns, the FDA has taken steps to ensure patients have clear and accurate information about the effectiveness and safety of biosimilar medicines. Already, there has been positive change as the agency has released both patient and provider educational materials highlighting the expected benefits of using a biosimilar.

The National Comprehensive Cancer Network (NCCN) updated its guidelines in May 2020 to include biosimilars as an appropriate substitute for all recommended uses of the reference biologic. Industry has played a role as well, as health system administrators have stated interest in credible, fact-based, educational materials from biosimilar manufacturers to provide to finance teams, medical teams and patients.

Responding to this need, Sandoz developed two educational campaigns – The Biosimilars Generation in Canada and The ABCs of Biosimilars in the US – to educate the public about the safety, efficacy and value of biosimilar medicines.

Given all of the progress in the field, the biosimilar market could also be improved by enacting common sense federal and state laws and regulations to encourage adoption of biosimilars by prescribers and patients and reducing overall healthcare spending. For example, changes to state laws and federal and state regulations could be enacted that would allow for formularies to adopt biosimilars rather than restricting use. In Medicare Part B, legislation could be passed to encourage physician adoption of biosimilars through a temporary increase in reimbursement and reduced cost sharing for beneficiaries.

Five years after biosimilars became available in the US, their role in delivering savings is more important than ever. A recent report from the American Hospital Association estimates the financial loss from COVID-19 from 1 March to 30 June 2020 to be $202.6bn, and some hospitals have been forced to close due to these losses. As the US responds to the public health and economic impacts of the COVID-19 pandemic, biosimilars stand out as a method of creating sustainability and improving patient care by expanding patient access to more affordable, high-quality, and potentially life-changing biologic treatments.

The launch of new biosimilars over the next five years has the potential to expand treatment options for the chronically ill, as well as allow greater use of specialty biologics by providing more affordable access to individuals who, in the past, have either forgone treatment or settled for less effective medicines.
This future is attainable if we continue to support a legal, regulatory and market environment that helps realise the full savings potential biosimilars can provide.

Robert Spina is VP of Key Accounts & Sales at Sandoz