Increasing Legislative Changes May Mark Turning Point in US Biosimilar Adoption

One of the most recurrent themes within the biosimilar industry revolves around the continued approval and introduction of adalimumab (Humira) biosimilars. Presently, despite the availability of 10 adalimumab biosimilars in the market, they collectively hold less than 2% market share, although most are priced substantially lower than the reference product.¹

This discrepancy creates a meaningful barrier to patient access to more affordable options, with only a small percentage of patients currently benefiting from these lower-cost alternatives. This is particularly troublesome for Medicare patients—potentially costing them thousands of dollars annually in out-of-pocket expenses.

A critical issue regarding biosimilar utilization lies in the impact on patients' treatment experiences. Clinicians often find themselves constrained by insurance company decisions, which can dictate the medications available to patients. In turn, patients may not receive the initial medication prescribed by their healthcare providers.

Additionally, clinicians are becoming increasingly interested in how biosimilar adoption will influence the patient journey. Although it is still too early to draw definitive conclusions, noted Benjamin Boone, MD, a rheumatologist at Rheumatology Associates, PLLC, there have been shifts in insurance formularies, leading some patients to switch medications.

“Ultimately, our primary concern is the wellbeing of our patients and the effectiveness of their treatment in managing their condition,” Boone told HCPLive.

How Pharmacy Benefit Managers Discourage Access

As biosimilars are a market-based solution to help with the affordability of specialty drugs in the US—in particular adalimumab in the rheumatic space—there is a real opportunity for patients to be part of the savings.

However, many experts point toward pharmacy benefit managers (PBMs) as the reason patients are unable to obtain access to these lower-priced medications.

“PBMs stifle free market competition and force Americans to pay more for the prescription drugs they need,” Reed explained in a statement responding to a press conference hosted by Senate Finance Committee Chair Ron Wyden, and Ranking Member Mike Crapo, in which they encouraged PBM reform. “Shockingly, 3 PBMs control 80% of the pharmacy benefit marketplace. This monopolistic system hurts patients by denying them access to critical, lower-cost, safe and effective prescription drugs.”²

Pharmaceutical companies have been pressured to offer significant rebates for access. This trend has become increasingly excessive and is heavily focused on satisfying payers. Companies that agreed to these high rebate demands experienced a substantial erosion in their average selling prices (ASPs), resulting in significantly decreased reimbursement for their products.

“When they begin to pay those payer rebates, the ASP completely tanks, and the providers stop using those products because there's no reimbursement in them,” explained Jorge J. García, PharmD, MS, assistant vice president of Baptist Health South Florida, to HCPLive. “That's when you begin to see these products go under water. This not only affects biosimilars but, in some cases, reference products.”

He and his team have been advocating for an at parity approach to biosimilars in which healthcare providers, patients, and the local market would have the freedom to choose the product that best suits their needs.

“Additionally, there should be clear benefits for payers when biosimilars are utilized, as these products come at a fraction of the cost compared to the reference product,” he said. “However, the challenge arises when payers seek both the billing benefit from using biosimilars and the pharmaceutical company rebate. However, some payers are beginning to recognize the importance of offering a variety of biosimilar choices in their benefit design, rather than prioritizing one product for a larger rebate. By requesting smaller rebates from each company, payers can support greater access to biosimilar options while still realizing cost savings.”

Additional Factors Inhibiting Uptake

Even if the science supports the functional identicality and effectiveness of biosimilars, adoption can still lag due to well-established habits in prescribing practices.

“First and foremost, rheumatologists, and physicians in general, are often creatures of habit,” Boone said. “We tend to take what we are experienced with, that we've used in the past, and carry that forward. That hasn't, until recently, involved adalimumab biosimilars. Therefore, it's just not as much of a habit of an individual to prescribe them since they are relatively novel.”

Typically, Boone explained, prescriptions are refills of existing medications patients have been treated with. Clinicians may be reluctant to switch patients from a bio-originator to a biosimilar unless necessary, particularly if the patient is responding well to their current treatment.

Additionally, Boone noted the number of biosimilars available in the market can overwhelm rheumatologists, making it challenging to stay informed about each one. This lack of awareness, combined with uncertainty about insurance formulary coverage for specific biosimilars, may lead prescribers to opt for treatments with fewer administrative barriers for patients. Unfortunately, this perpetuates the issues surrounding a slow uptake of these equally effective, lower-cost treatment options.

However, recent growth observed in biosimilar uptake may be attributed to the implementation of formularies, prompting prescribers to make necessary changes, as well as increased efforts by pharmaceutical companies to educate clinicians about their biosimilar offerings, leading to both greater awareness and utilization.

Emem Adolf-Ubokudom, MD, a rheumatologist at Cambridge Health Alliance and an instructor at Harvard Medical School, further emphasized the importance of patient education in the journey towards biosimilar acceptance and uptake.

“Biosimilars have been used in Europe for a much longer time than here,” she told HCPLive. “But I think people have to understand [more about biosimilars] as we move into the the next wave of how we manage rheumatology patients. [As clinicians], we need to get into the habit of educating patients.”

Legislation Increases Awareness, Optimism

Despite the many challenges, there is hope surrounding the commitment of biosimilar developers to offer cost-effective options, with efforts underway to circumvent PBMs and increase patient access.

In October 2023, the Department of Health and Human Services (HSS) Secretary Xavier Becerra released a statement regarding the approval of ustekinumab-auub, an interchangeable biosimilar, for the treatment of inflammatory diseases. Additionally, the introduction of the Inflation Reduction Act helped to encourage competition within the market by removing some of the barriers that were blocking biosimilars and generic drugs from entering the market.³

"Americans pay too much for prescription drugs,” he stated at the time. “Lack of affordable access to prescription drugs and other health care services leads to worse health outcomes. “That is why the Biden-Harris Administration has made it a top priority to lower health care costs and make sure every American has access to affordable, high quality health care. Increasing competition and the availability of lower cost biosimilars for high-cost prescription drugs is a key part of that effort.”³

The HSS Office of the Inspector General and other entities are currently examining these practices and taking steps to rectify the situation with legislative intervention.

In 2021, US senators Michael Bennet and John Cornyn introduced the Increasing Access to Biosimilars Act, which aimed to increase the availability of biosimilar biological products under the Medicare program.⁴

Recently, they reintroduced a similar bill requiring the Secretary of Health and Human Services to establish a demonstration project to increase access to these medications.

“Too often, seniors have been hit the hardest by out-of-control drug costs. It is time to put patients first,” Reed remarked of the bill’s reintroduction. “This bipartisan legislation would increase patient access to lower-cost biosimilars, encourage competition by promoting the use of biosimilars, and save our nation’s seniors and the health care system billions of dollars.”¹

Additionally, the US Department of Veterans Affairs (VA), one of the largest healthcare delivery systems in the US that provides high quality care nearly 9 million qualified veterans and their family members, announced its exclusive selection of biosimilar adalimumab-bwwd (Hadlima) in replacement of the reference drug for the VA National Formulary.⁵ This initiative in the biosimilar market highlights a significant healthcare system advocating for structural changes that can positively impact the biosimilar market. Jon Martin, US Commercial Lead of Biosimilars at Organon, and his team anticipate more healthcare segments across the US to follow suit in the future.

“This is a great example of the private sector working with the public sector to improve drug affordability,” Martin said in an interview with HCPLive. “We're really excited about what this can be both to the VA in terms of the savings that will provide without compromising care, as well as an early indicator of forming formation of this biosimilar market and the broader US market.”⁶

Biosimilars: 2024 and Beyond

García emphasized what is advantageous about adalimumab is the array of options currently available and the diverse strategies in place for introducing the product. However, he believes it will ultimately require PBMs some time to strategize on the short-term and long-term impacts of biosimilars.

“PBMs are still trying to understand how they're going to handle this from a legal standpoint, from an operational standpoint, and from an economic standpoint,” García said. “The boom is probably still ahead of us.”

Looking ahead, Reed and her team predict ongoing developments in biosimilar approvals and discussions on scientific advancements, with legislative actions and market reforms driving change. Collaboration among stakeholders, including patient groups, healthcare providers, and regulatory agencies, may be crucial factor in addressing these issues and ensuring widespread access to biosimilars.

“When you look at what the future potential could be for biosimilars in the United States, being a pro-competition market, it leads you to believe that over time the biosimilars will be one of the solutions to help address the affordability in the US both from the system perspective as well as patients,” Martin said.⁶

References

1. ^{Biosimilars Forum announces support for increasing access to Biosimilars Act. Biosimilars Forum Announces Support for Increasing Access to Biosimilars Act. March 20, 2024. Accessed April 3, 2024. https://biosimilarsforum.org/2024/03/20/biosimilars-forum-announces-support-for-increasing-access-to-biosimilars-act/.}
2. ^{Biosimilars Forum urges Congress to support free market competition and lower prescription drug prices for patients by reforming pharmacy benefit managers. Biosimilars Forum Urges Congress to Support Free Market Competition and Lower Prescription Drug Prices for Patients by Reforming Pharmacy Benefit Managers. March 14, 2024. Accessed April 3, 2024. https://biosimilarsforum.org/2024/03/14/biosimilars-forum-urges-congress-to-support-free-market-competition-and-lower-prescription-drug-prices-for-patients-by-reforming-pharmacy-benefit-managers.}
3. ^{Becerra X. HHS secretary Becerra’s statement on the FDA’s approval of Wezlana. HHS.gov. November 1, 2023. Accessed April 3, 2024. https://www.hhs.gov/about/news/2023/10/31/hhs-secretary-becerras-statement-fdas-approval-wezlana.html.}
4. ^{Bennet, Cornyn introduce bipartisan bill to increase access to biosimilar drugs. Bennet, Cornyn Introduce Bipartisan Bill to Increase Access to Biosimilar Drugs. April 30, 2021. Accessed April 3, 2024. https://www.bennet.senate.gov/public/index.cfm/2021/4/bennet-colleagues-introduce-bill-to-help-wounded-veterans-start-a-family.}
5. ^{Organon announces HADLIMATM (Adalimumab-bwwd) has been exclusively selected by the US Department of Veterans Affairs (VA), replacing Humira on its National Formulary. Organon. February 20, 2024. Accessed April 3, 2024. https://www.organon.com/news/organon-announces-hadlima-adalimumab-bwwd-has-been-exclusively-selected-by-the-us-department-of-veterans-affairs-va-replacing-humira-on-its-national-formulary/.}
6. ^{Pine L. The US Department of Veterans Affairs announces adoption of Adalimumab-BWWD, with Jon Martin. The US Department of Veterans Affairs Announces Adoption of Adalimumab-bwwd, with Jon Martin. March 7, 2024. Accessed April 3, 2024. https://www.hcplive.com/view/the-us-department-of-veterans-affairs-announces-adoption-of-adalimumab-bwwd-with-jon-martin.}