The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability

Our health care spending as a country is more than any other country in the world (including all developed countries) both in total cost and on a per capita basis as well as percentage of gross domestic product. However, outcomes are not matched compared to spending and in some cases our health care system underperforms other countries.

In 2022, our health care spending rose to $4.5 trillion in health care and is projected to increase even further, to nearly $6 trillion in 2027.¹ Rising health care costs not only poses a threat to sustainability, but also increases risk of outcomes due to increase in financial toxicity. The US biologics market has grown 12.5% annually on average over the last 5 years on an invoice-price basis, faster than nonbiologics. In 2021, the United States spent $568 billion on medicines including $260 billion on biologics. Spending on biologics comprise 46% of total pharmaceutical spending but only 2% of total prescriptions.²

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Thus, understanding and creating competitive markets in biologics would facilitate addressing multiple challenges emanating from ever escalating drug prices particularly in biologics market. Entry of biosimilars in 2015 in US health care (almost a decade after European Union in 2006) has a potential to save close to $181 billion provided appropriate assimilation through multiple tiers from manufacturers of biosimilars, smoother regulatory approvals, provider acceptance and payer and pharmacy benefit manager (PBM) cooperation.

Congress passed the Biologics Price Competition and Innovation Act (BPCIA) 2009, creating a pathway for biosimilars entry and approvals in the US. Biosimilars have no clinically meaningful differences in safety, purity, or potency. They must undergo the same rigorous standards set forth by the FDA for reference biologics. However, they have enormous potential to address financial toxicity at an individual level, insurance level and health care system level as whole. Biosimilar competition may help decrease reference product pricing. Due to archaic implementation system though it took almost 6 years from the passage of the BPCIA in 2009 the first biosimilar approval happened in 2015. Despite slower initial uptake, biosimilar launches in the last 5 years have generally been more successful than earlier. This fact raises hopes that savings and patient access could increase substantially.

While uptake of biosimilars has not been equal amongst all specialties, oncology has led the adoption of biosimilars the most. Pegfilgrastim and epoetin alfa biosimilars, both launched in 2018, have seen moderate uptake achieving 37% share of molecule volume in the first 3 years. Pegfilgrastim biosimilar share has continued to rise slowly. The 3 other molecules with biosimilar launches in 2019—bevacizumab (82%), trastuzumab (80%), and rituximab (67%)—achieved significant uptake within the first 3 years. Oncologists have paved the way for successful integration of biosimilars.

In 2023, a major shift happened in the biosimilars market with the launch of the biosimilars for some of the most widely used drugs in the world. It is well documented that biosimilars can dramatically reduce health care costs. Savings from biosimilar adoption could range from $38.4 billion to $124.5 billion from 2021 to 2025, according to a 2022 study.³ Biosimilars cost an average of 30% less than reference biologics—a critical factor given that biologics represent 2% of all US prescriptions but nearly 40% of net drug spending.^{4 ,5}

However, despite huge success in the oncology biosimilars arena, the adoption of biosimilars in other medical specialties has not been a huge success. Infliximab has seen the lowest adoption of biosimilars, with volume share at 3% after 1 year and rising slowly to 13% after 3 years.

The introduction of lower cost biosimilars has led to declines in overall molecule costs per unit of biologic and/or biosimilar. This has over time, driven down costs for originators as well.

Biosimilars were one of the first realistic alternatives that would allow the provision of appropriate affordable care to tens of millions of Americans in multiple ways from reducing out-of-pocket costs to impacting financial toxicity in a positive way. We all have a collective responsibility of embracing, adapting, and administering biosimilars to address issues from the ecosystem level, from the individual patient to the health system across the country.

As we continue to see widening gaps in access to care increasing risks to bankruptcies due to debts arising out of medical care, innovative approaches for acceptance, assimilation, and adoption of biosimilars is a must to reduce disparities. Financial toxicities are very well recognized cause of adverse outcomes where a patient may prefer food over expensive drugs. Biosimilars offer a realistic option at multiple levels as a solution.

Unlike Europe, where biosimilars were first approved in 2006 and have become a household entity, entry, introduction, and assimilation of biosimilars in the therapeutic armamentarium has not been without challenges. First, even after passage of BPCIA it took almost 5 years to introduce the first biosimilar. Then there was a struggle between biosimilars and biologics where a legislative push took place to lump all biosimilars in one J code (which would have led to downward spiral of average sales price eventually triggering premature failure).

I was very heavily involved in supporting biosimilars as chairman of biosimilars committees for Community Oncology Alliance and the Association of Community Cancer Centers. I reached out to the Office of Management and Budget Office under Director John Michael "Mick" Mulvaney and the White House office supporting initiative to create unique Q codes which eventually happened. Then, I took a personal initiative to start writing, publishing, and educating my colleagues about the role of biosimilars at individual level and in value-based care.

While Medicare beneficiaries with cancer and supportive drugs in cancer saw quick uptake reducing out-of-pocket costs, with rising number of beneficiaries who are now on Medicare Advantage plans and Managed Care Organizations managing Medicaid Benefits, have not yielded full benefit of adoption of biosimilars due to some of occult policies by the PBMs advising insurance plans. PBMs have started creating favorites and preferred lists, restricting coverage to 1 biosimilars (and frequently, the most expensive) placing unnecessary burden on providers to succumb to pass on higher out-of-pocket costs to consumers and patients once again risking financial toxicities. Nevertheless, hope is eternal and eventually payers and law makers will realize the obstacles to fair and just place for biosimilars in day-to-day use and unfair practices will be corrected.

References

CMS. National Health Expenditures: 2022 Highlights. 2023. Accessed March 1, 2024. https://www. cms.gov/files/document/highlights.pdf

2)Biosimilars in the United States 2023-2024: Competition, savings and sustainability. IQVIA. January 31, 2023. Accessed March 1, 2024.

3) Mulcahy A, Buttorff C, Finegold K, et al. Projected US savings from biosimilars, 2021-2025. Am J Manag Care. 2022;28(7): 329-335. doi:10.37765/ajmc.2022.88809

4) New Report finds biosimilars could save states billions of dollars annually. Biosimilars Forum. October 2021. Accessed March 1, 2024. https://biosimilarsforum.org/2021/10/13/new-report-finds-biosimilars-could-save-states-billions-of-dollars-annually/

5)HHS Inspector General report: Biosimilars could generate significant Medicare Part D savings. Biosimilars Forum. March 2022. Accessed March 1, 2024. https://biosimilarsforum.org/2022/03/31/hhs-inspector-general-report-biosimilars-could-generate-significant-medicare-part-d-savings/