Contributor: The Promise of Biosimilars and the Harsh Reality of the US Market

Biological products, or biologic drugs, have transformed the way patients with many diseases, including cancer, are treated. As biologic drugs lose their patent protection, there exists an opportunity for the introduction of biosimilar drugs. A biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine. It may be used in patients who have been previously treated with the reference product, as well as patients who have not previously received the reference product.

Quality without sacrifice is the promise of biosimilars. In theory, by offering a lower-cost treatment option, biosimilars would help drive access for countless patients who simply could not afford the brand-name biologic. Biosimilars have also encountered the harsh realities of the US health care system and its market forces.

Since 2007, 30 biosimilars have launched in the United States, with at least 10 more biosimilars approved and set to launch by the end of 2023.¹ There are now multiple approved biosimilars of rituximab (Rituxan, Genentech), trastuzumab (Herceptin, Genentech), and bevacizumab (Avastin, Genentech); in the supportive therapy category, there are multiple biosimilars for filgrastim (Neupogen, Amgen), pegfilgrastim (Neulasta, Amgen), and a biosimilar for epoetin alfa (Epogen/Procrit, Amgen/Janssen).

There are biosimilars approved or in clinical development in the United States for 20 molecules in addition to the 12 with biosimilars already launched.² At least 5 more biosimilars are scheduled to enter the US market in 2023 as biosimilar versions of adalimumab (Humira, AbbVie), which is used to treat rheumatoid arthritis, Crohn disease, ulcerative colitis, and several other conditions.

The prescribing of biosimilars saved the US health care system $7.9 billion in 2020, more than tripling the $2.5 billion saved in 2019, according to the Association for Accessible Medicines, the trade association of generic and biosimilar manufacturers.³ Use of lower cost biosimilars has provided $12.6 billion in savings since 2011.Savings as a result of biosimilars has been estimated between $85 billion and $133 billion in aggregate by 2025.¹

A study of the Community Oncology Alliance practices found a dramatic increase in the adoption of biosimilars for bevacizumab and trastuzumab, which were first marketed in July 2019.⁴ In the fourth quarter of that year, participating practices reported 8,000 administrations of bevacizumab vs 21,000 for the reference product, representing a 29% share of administrations for biosimilar bevacizumab.

By the fourth quarter for 2020, bevacizumab biosimilars had achieved a 72% share of the administrations, or roughly 31,000 in total and 18,000 for bevacizumab biosimilars vs. 13,000 for the reference product. Additionally, the participating practices also reported a 27% increase in number of patients treated once biosimilars entered the market—by making therapy more affordable, more patients were able to be treated.

However, biosimilars have experienced a rough time in the United States.

Payer coverage for biosimilar treatments has improved greatly over the last 2 years, yet providers continue to face familiar obstacles. Some payers require the reference product, and others prefer the reference product so that the reference product must be used prior to the patient trying a biosimilar for that product.

Although biosimilar drugs are generally priced lower, stakeholder incentives are not always aligned to enable or support biosimilar adoption. Pharmacy benefit managers (PBMs) are companies that manage pharmacy benefits for health insurers, Medicare Part D drug plans, large employers, and other payers.

Despite the fact that the role of a PBM is to control drug spending, the manufacturer that provides the largest rebate wins the preferred product slot on the formulary, even if the drug is more expensive than other options, such as a biosimilar. As a result, patients who have a high-deductible plan or have co-pays based on a drug’s list price may incur higher out-of-pocket costs.

Another obstacle hindering biosimilar adoption is Medicare’s reimbursement rules, which do not incentivize clinicians to prescribe lower cost drugs, such as biosimilars, and actively reward the prescribers of higher priced drugs.

And now biosimilars appear to be suffering from the Law of Unintended Consequences. With days left in 2022, Pfizer quietly announced they would no longer cover biosimilars through their Patient Assistance Program, which offers free or low-cost medications to patients who are uninsured or underinsured.

For the underinsured patients whose insurance will only authorize the Pfizer biosimilars, it means they no longer have access to these potentially life-saving medications. For payers that have a more open formulary, it still results in a delay in care due to reauthorization of the new preferred medicine. If other biosimilar manufacturers follow in Pfizer’s footsteps, the biosimilar market will collapse, brand products will raise their prices back to pre-competition average sales price and, most importantly, patients will suffer due to increased health care costs and lack of access.

We can and need to do more to support a healthy biosimilar market. Congress, CMS, commercial payers, and biosimilar manufacturers all should take a hard look at the benefits biosimilars have provided to the many stakeholders in the US health care system (and most importantly, the patients we care for) and implement payment methodology and policies to ensure biosimilar drugs continue to have the potential to provide more treatment options, improve access to lifesaving medications, and lower health care costs through increased competition.

References

1. Biosimilars in the United States 2020-2024. IQVIA Institute for Human Data Science. October 2021. Accessed February 17, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2020-2024
2. Biosimilars in the United States 2023-2027. IQVIA Institute for Human Data Science, January 2023. Accessed February 17, 2023. https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027
3. The US Generics and Biosimilar Medicines Savings Report. Association for Accessible Medicines. 2021. Accessed February 17, 2023. https://accessiblemeds.org/resources/reports/2021-savings-report
4. Tony Hagen. COA Reports Improved Biosimilar Access in Oncology. AJMC. November 15, 2021. Accessed February 17, 2023. https://www.ajmc.com/view/coa-reports-improved-biosimilar-access-in-oncology