Part 1: Unlocking the Potential of Biosimilars to Improve Health Equity

Over the past decade, biosimilars have emerged as a transformative force within the pharmaceutical landscape. Initially introduced in Europe, they have steadily gained traction in the United States, proposing an increased patient access to life-saving medications at lower costs.

Biosimilar development hinges on rigorous scientific comparisons. Extensive data analysis, including clinical pharmacokinetic similarities, forms the backbone of these evaluations. Biosimilars undergo meticulous scrutiny to ensure they match the efficacy, safety, and immunogenicity profile of their brand name counterparts.¹ Ultimately, FDA approval signifies that no clinically meaningful differences exist between the biosimilar and the originator biologic drug.

However, a concerning trend has emerged, with clinician familiarity of biosimilars falling below expectations, hindering their prescription rates. Given their cost effectiveness and near identical characteristics to brand name drugs, why are biosimilars not achieving the market adoption they deserve?

This marks the first installment of a 2-part series, brought to you by The Center for Biosimilars^®. We will delve into the potential of biosimilars to empower underserved communities while dissecting the obstacles that currently prevent them from accessing these affordable treatments.

Our series, titled "Unlocking the Potential of Biosimilars to Improve Health Equity," will shed light on the significant knowledge gaps within the medical field. The 2-part series kicks off by exploring medical mistrust in underserved communities and the knowledge gaps created by critical barriers faced by both patients and healthcare professionals. In part 2, focus is shifted on the role of payers, pharmacy benefit managers, and the financial incentives that influence prescription choices.

Biosimilars hold promise for affordable treatment options while maintaining the same safety and efficacy compared with their originators, but barriers from pharmacy, physician, and insurance groups limit patient access to health equity, especially for underserved communities.

Biosimilars: Affordable, Effective Treatments

Patient access to biosimilars allows earlier treatment access which can result in improved outcomes by controlling symptoms and reducing symptom severity. Biosimilar sales are typically priced 11% to 45% lower than originators and promote considerable savings for eligible patients.¹ Since the Biologics Price Competition and Innovation Act (BPCIA) of 2009 was passed, biosimilars have generated $37 billion in savings, despite slow uptake in some markets.

As more biosimilars launch and experience increased uptake, losses for originator products are expected to rise from $111 billion to $192 billion by the end of 2028.² In its Global Use of Medicines report, the IQVIA Institute for Human Data Science estimated the spending on reference products will decrease $39.5 billion over the next 5 years thanks to biosimilar competition. The future holds significant promise for biosimilars with global use potentially growing to 3.8 trillion daily doses by 2028, an overall 400 million increase compared with 2023.

In an interview with The Center for Biosimilars, Robert Popovian, Pharm.D, MS, a health economist, and founder of Conquest Advisors, stated, “We need to address benefit design. Over the last 10 years there’s been coinsurances and deductibles introduced in the benefit design for biopharmaceuticals. Because of that, [drug prices] are a little bit of an unknown.”

While the potential advantages of biosimilars are undeniable, realizing their full impact can be a complex process with the current policies in place. To ensure biosimilars can provide all patients with adequate care and savings, stakeholders will need to address some of the challenges that exist and propose potential solutions for navigating them effectively.

Biosimilars in Underserved Communities

Accessibility and Affordability

In the US, people without health insurance often have trouble accessing affordable health care. One study found non-White populations were 70% more likely to not have health insurance in comparison to their Caucasian counterparts.³ In addition, geographic areas that have limited access to doctor’s offices and other facilities had higher populations of non-White communities. Black families were also twice as likely as White families to live in poverty, making an average of $52,860 yearly income compared with $81,060 for non-Hispanic White annual income.

White people living among rural populations are also affected by inadequate health care at higher rates compared with White people living in urban areas. With one-fifth of the American population occupying rural regions, local hospitals and access to care are limited.⁴ From 2013 to 2020, about 4% of rural hospitals closed in the US, leaving residents with 20 miles to 40 miles of travel.

Biosimilars are intended to offer effective treatments to various communities and illnesses no matter their financial status. With the emergence of self-injectable and on-body drug administration options for biosimilars, patients can reduce their dependence on hospital facilities and drug delivery related health care costs.

Subcutaneous administration is significantly beneficial by making drug delivery less time consuming for patients from underserved communities as many of these patients with conditions requiring biologic therapies are unemployed or working part-time based on the severity of their condition. This option helps patients living further from the hospital or those who do not have a reliable means of travel. Minimizing travel can also reduce the risk of exposure to hospital-acquired infections among patients and any accompanying companions.⁵

Considering the financial inequalities non-White communities face, biosimilar competition proposes lower costs for the whole market, including the reference product. Systemic evidence found competition has resulted in marginal price decreases, with biosimilars being priced only about 30% less than their originators.⁶ Overall, this represents an average discount of $665 off the typical price. Biosimilars offer the potential for significant cost savings, with research suggesting a 4.3 times higher savings rate compared with generics. However, the question of whether these savings translate directly to patient affordability remains complex and will be explored further in part 2 of this series.

Medical Mistrust Leads to Treatment Hesitancy

Biosimilars have the potential to promote greater accessibility and affordability to non-White populations, but current access is limited due to factors like medical mistrust and racial inequalities in health care. Historically, underserved populations endured various forms of medical malpractice, specifically Black people. Ultimately, this has led to loss of trust among non-White communities, racial prejudices in the health care sector, and a neglect in treatment for these populations.

In a Canadian study, Black patients were found to be less likely to receive biologic treatment for several medical conditions.⁷ The US sees similar patterns as there is a lot of medical mistrust among Black communities, stemming from a long history of unethical medical practices that have harmed them. Some of the most prominent, documented forms of medical malpractice were conducted on enslaved women by James Marion Sims, MD, between 1845 to 1849, who is now referred to as “the father of gynecology.”⁸ Sims operated on his participants, often enrolled by their enslavers, without anesthesia because he was under the racist belief that “Black people did not feel pain.”

Almost 100 years later, unethical medical malpractice continued throughout the 1930s, notably the Tuskegee experiment, which is often cited as a major stimulus for the mistrust of medical advances among Black populations.⁷ Similarly to the enslaved women, some 600 African American participants did not express informed consent and were not offered treatment if infected with syphilis, despite medical advancements becoming widely available.

Additionally, the little representation of Black and Indigenous health care workers is not nearly equivalent to other races. Unequal access to quality health care and a history of mistreatment has led to a gap in trust when it comes to new medical developments for underserved populations.⁷

The mistrust non-White communities have towards health care professionals contributes to biologic treatment hesitancy. In a US study, results found higher levels of unfamiliarity of biologic therapies in Black patients compared with White patients.⁷ The knowledge gaps non-White communities have towards biologics or false information is largely due to the lack of comfort they have in asking health care professionals and trusting the feedback they receive.

Racial inequalities Black patients experience resulted in the decreased likelihood they would receive reference trastuzumab for breast cancer treatment. Trastuzumab, a biologic rapidly growing in US cancer care, holds potential for the reduction of health care inequalities but often dismisses marginalized communities in study populations.⁹

Clinical trials aim to prove the safety and effectiveness of biosimilars, but the health care system has low participation of non-White populations, furthering their medical mistrust. A study found only 2.6% of global cancer clinical trials included Black participants.⁷ Aside from general representation, demographic variety is important because it reveals any inter-ethnic differences in drug responses and metabolism. This lack of representation in clinical trials can only be addressed if there is a significant shift in how health care builds trust with minority communities.

Additionally, the lack of transparency pharmacy benefit managers (PBMs) have with patients furthers this medical mistrust. The 3 PBMs that control around 80% of the market are CVS Caremark, Express Scripts, and Optum Rx, which are all operated by major health insurers and/or owned by a pharmacy.¹⁰ These PBMs are ultimately negotiating with themselves or 1 of their competitors to create financial incentives that benefit themselves while negatively impacting patients.

Chiara Gasteiger, PhD, of Stanford University’s Mind and Body Lab researching as a postdoctoral scholar explained in an interview, “To combat trust issues among patients, providers, and physicians, there needs to be more transparency on the role of PBMs [pharmacy benefit managers], their negotiation processes and disclosure of rebate retentions to build trust and understanding from stakeholders, health care providers, and policymakers. Existing regulations should also ensure that PBMs comply with laws that protect patients and encourage fair pricing.”

Transparency around PBMs is crucial and these efforts must be coupled with addressing the everyday challenges faced by patients that create mistrust, particularly in underserved communities. Bureautic hurdles, such as language or health literacy, disproportionately affect underserved communities in several ways. A 2020 survey on race and health revealed 20% of both Black and Hispanic adults reported unfair treatment based on race or ethnicity in health care within the past year.¹¹ In a separate survey from 2021, 24% of Hispanic adults expressed it was “very” or “somewhat difficult” to find a physician that was able to explain things in a way they could easily understand.

Underserved communities, burdened by limited advocacy, finances, and often low health literacy, struggle to access essential medications. Biosimilars, offering comparable treatments at lower costs, can empower these communities towards better health outcomes.

Communication, Education

Popovian described a study he participated in where he found, “it's not just health literacy and education of patients. It's also health literacy and education of health care providers,” in reference to the existing knowledge gaps surrounding biosimilars.

Further communication between physicians and patients would allow underserved, underrepresented communities to establish a level of trust with health care systems. Language barriers include complicated medical terminology, differing dialects between patient and physicians, and providers often being unable to communicate in non-native English speakers’ primary languages.

Gasteiger suggested, “Information should be presented in a language and communication style that aligns with the patient’s health literacy and cultural norms, including the option to have a support person present.” It is up to health care systems to work with the patient and their caregivers on the status and severity of the patient’s condition and potential treatment options.

Gasteiger argued that physicians building rapport with their patients helps establish trust, enabling open dialogue about concerns, especially when providers are transparent about funding limits. Bridging knowledge gaps and addressing the evolving needs of each unique patient and their families must be tailored through collaboration, reiteration, and flexibility among providers.

She suggested “Transparent patient and family-centered communication and shared decision-making should be encouraged to build trust and promote patient autonomy. Small nudges can also be used to encourage more positive perceptions of biosimilars, such as through positive message framing and carefully balancing risk benefit information.

With the little representation of most underserved communities, health care providers can seem intimidating to certain patients, ultimately preventing them from participating in the decision-making process. Furthermore, increased access to information in the modern age leads to an increased risk of spreading misinformation, leaving vulnerable populations at risk for false theory consumption.

“It is important to empower patients to identify misinformation and provide credible supportive material. Implementing more guidelines for media reporting on biosimilars could further help to combat misinformation,” Gasteiger stated.

Gaining multiple opinions and expanding research upon treatments can be beneficial in educating patients and physicians. The FDA website has multimedia educational resources on biosimilars and interchangeable products for patients, caregivers, and health care providers.¹² These materials are available in multiple formats and languages. Fortunately, some of the educational resources are also offered through videos, an important factor for populations with low literacy rates.

“More education, such as on testing and manufacturing, needs to be integrated into medical training curriculums and all providers should have access to comprehensive training programs that are regularly updated with new designations, guidelines, and policies,” Gasteiger suggested as a solution.

Popovian commented, “We need to do quite a bit of education but it's super important to be able to do it both on the health care professional side and on the patient side. It's also important to understand that especially that education is important for patients on chronic care medicines that they've been taking for very long.”

Through collaborative communication, culturally sensitive education, and a commitment to shared decision-making, health care providers can unlock the potential of biosimilars for underserved communities, empowering patients to make informed choices about their health.

References

1. Shubow S, Sun Q, Nguyen Phan AL, et al. Prescriber perspectives on biosimilar adoption and potential role of clinical pharmacology: A workshop summary. Clin Pharmacol Ther. 2023;113(1):37-49. doi:10.1002/cpt.2765

2. Jeremias S. IQVIA predicts biosimilar, generic competition will cost originators $192 billion by 2028. Drug Topics. January 19, 2024. Accessed March 29, 2024. https://www.drugtopics.com/view/iqvia-predicts-biosimilar-generic-competition-will-cost-originators-192-billion-by-2028

3. Health O of M. Advancing better health through better understanding for black and african american communities: Health literacy, health care access, and culturally appropriate care 2024 reading list. www.hhs.gov.

January 30, 2024. Accessed March 29, 2024. https://www.hhs.gov/black-history-month/readinglist/index.html#:~:text=Black%20households%20are%20twice%20as

4.Hundrup A. Why health care is harder to access in rural America. U.S. GAO. May 16, 2023. Accessed April 25, 2024. https://www.gao.gov/blog/why-health-care-harder-access-rural-america

5.Jonaitis L, Marković S, Farkas K, et al. Intravenous versus subcutaneous delivery of biotherapeutics in IBD: an expert's and patient's perspective. BMC Proc. 2021;15(17):25. doi:10.1186/s12919-021-00230-7

6. Goldman D, Philipson T. Biosimilars competition helps patients more than generic competition. STAT. October 8, 2021. Accessed March 29, 2024. https://www.statnews.com/2021/10/08/biosimilars-competition-helps-patients-more-than-generic-competition/

7. Akuffo-Addo E, Udounwa T, Chan J, Cauchi L. Exploring biologic treatment hesitancy among black and indigenous populations in Canada: a review. J Racial Ethn Health Disparities. 2023;10(2):942-951. doi:10.1007/s40615-022-01282-x

8. Holland B. The “father of modern gynecology” performed shocking experiments on slaves. History.com. Published December 4, 2018. Accessed March 29, 2024. https://www.history.com/news/the-father-of-modern-gynecology-performed-shocking-experiments-on-slaves

9. Petrullo J. Biosimilars can expand treatment access for traditionally excluded communities. Center for Biosimilars. July 18, 2023. Accessed March 29, 2024. https://www.centerforbiosimilars.com/view/biosimilars-may-expand-treatment-access-for-traditionally-excluded-communities

10. Hearing wrap up: Pharmacy benefit managers push anticompetitive drug pricing tactics to line their own pockets - United States house committee on oversight and accountability. Press release. United States House Committee on Oversight and Accountability; October 2, 2023. Accessed April 25, 2024. https://oversight.house.gov/release/hearing-wrap-up-pharmacy-benefit-managers-push-anticompetitive-drug-pricing-tactics-to-line-their-own-pockets%EF%BF%BC/#:~:text=But%20that%20environment%20of%20competition,is%20owned%2C%20by%20a%20pharmacy.

11. Ndugga N, Artiga S. Disparities in health and health care: 5 key questions and answers. Kaiser Family Foundation. April 21, 2023. Accessed March 29, 2024. https://www.kff.org/racial-equity-and-health-policy/issue-brief/disparities-in-health-and-health-care-5-key-question-and-answers/

12. Multimedia Education Materials, Biosimilars. FDA. 2024. Accessed April 1, 2024. https://www.fda.gov/drugs/biosimilars/multimedia-education-materials-biosimilars#For%20PatientsDD