Biosimilars in Oncology Can Reduce Healthcare Costs

Approximately 40% of American men and women will be diagnosed with cancer at some point in their lives,¹ with the cost of cancer care in the United States projected to exceed $245 billion by 2030.²

Rising cancer treatment costs strain family budgets and healthcare plan funds, which directly impact patient care. For example, a novel biologic therapy may cost more than $10,000 a month, which is double the US median monthly household income.³ Biologic-based medicines accounted for 38% of US prescription drug spending in 2015 and 70% of drug spending growth between 2010 and 2015.⁴

A biosimilar is a biologic agent with no clinically meaningful difference from its FDA-approved reference product; hence, biosimilars are approved by the FDA via a truncated process. As part of the shortened approval process, key characteristics, including purity, molecular structure, and bioactivity, are evaluated against the reference product, and they are thus substantially less expensive to achieve FDA approval compared with the reference product.⁶

Although data are limited, one study estimated that by introducing biosimilars into clinical practice, the US health system could save $54 billion by 2026, with savings ranging between $25 billion and $150 billion.⁴ Expanding the biosimilar market, especially in oncology, allows clinicians to identify less costly medications to advance cancer treatment and supportive care.⁵

Rising Adoption of Biosimilars

Biosimilar drug use has increased in the United States. Between 2018 and 2023, the biosimilar industry grew by 12.5% annually and now accounts for more than 46% of spending.⁷

Moreover, launches and usage of biosimilars are expected to substantially increase overall spending by $20 billion to $49 billion by 2027. This increase in spending reflects how biosimilars are encroaching on the market share of the reference drugs.⁷

Clinician Education Key to Mitigating Slow Uptake of Biosimilars

Despite the potential to lower costs of cancer care with biosimilars, cost savings have been limited in the United States.⁸ Knowledge gaps surrounding safety and efficacy among clinicians and patients have resulted in slower uptake of biosimilars in the United States.

Educational programs are available to support clinician and patient understanding regarding biosimilar development, regulatory policies, and preclinical and clinical evidence supporting the efficacy and safety of biosimilars.⁸ One point of emphasis has been that all FDA-approved biologic agents undergo a rigorous evaluation, and biosimilar manufacturers use comparisons to the reference product to support approval and establish safety and effectiveness. This process is intended to avoid the expense and time commitments associated with clinical trials (Figure). Despite this truncated process, the pathway to biosimilar approval is still rigorous.⁸

Interchangeability

Unlike generic versus brand drugs, pharmacists cannot automatically substitute a biosimilar agent for the reference biologic agent without the prescriber’s permission. However, pharmacists may substitute a biosimilar drug for the reference biologic without permission if the FDA has determined that the biosimilar agent is “interchangeable.” For a biosimilar to receive a designation as interchangeable, additional clinical studies are required to demonstrate that the biosimilar agent would produce the same clinical result as the reference biologic in any given patient.^9,10 This would include performing switching studies in which patients alternate between the reference biologic and the biosimilar multiple times over a specified period of time.⁸ Currently, no biosimilar drugs have been FDA-approved as interchangeable in oncology; however, the FDA has approved 4 interchangeable biosimilar products for certain ophthalmic and inflammatory diseases and diabetes.⁸

Notable Oncology Biosimilars

As of March 2024, the FDA has approved more than 20 biosimilars cancer treatments (Table)^11,12 that work via various mechanisms of action.

Bevacizumab (Avastin) blocks vascular endothelial growth factor, a protein that some cancer cells produce in substantial amounts.¹³ Bevacizumab is used to treat colorectal; lung; glioblastoma; kidney; epithelial ovarian, fallopian tube, or primary peritoneal; cervical; and hepatocellular cancers.¹⁴ Biosimilars of bevacizumab include Mvasi, Zirabev, Alymys, Veglezma, and Avzivi. All biosimilars of bevacizumab are administered intravenously and are approved to treat the same cancers as bevacizumab, although they are not approved to treat liver cancer.¹⁵

Biosimilars can also treat cancer by targeting HER2, a protein that, when overexpressed, can cause cancer cells to grow out of control. Trastuzumab (Herceptin) binds to the extracellular domain of HER2, inhibiting its signaling.¹⁶ Biosimilars of trastuzumab include Ogivri, Herzuma, Kanjinti, Herzuma, and Ontruzant. Trastuzumab is approved to treat breast cancer and gastric or gastroesophageal junction adenocarcinoma, as are the trastuzumab biosimilars.^17,18

PD-1/PD-L1 Inhibitors Biosimilars

Treatment with antibodies that inhibit the interaction between PD-L1 and its receptor, PD-1, can inhibit tumor growth.¹⁹

PD-1/PD-L1 inhibitors, such as pembrolizumab (Keytruda), are used as a front-line treatment for melanoma; non–small cell lung cancer; head and neck and squamous cell carcinomas; classical Hodgkin and primary mediastinal large B-cell lymphomas; urothelial, microsatellite instability-high or mismatch repair deficient, microsatellite instability-high or mismatch repair deficient colorectal, triple-negative breast, biliary tract, and gastric cancers; hepatocellular, Merkel cell, renal cell, and endometrial carcinomas; tumor mutational burden-high cancer; and cutaneous squamous-cell carcinoma.²⁰

Biosimilar versions of pembrolizumab include InVivoSIM anti-human PD-1.21 SB27 is a biosimilar for pembrolizumab from Samsung Bioepis and is in phase 3 trials.²²

The human immunoglobulin G1 kappa monoclonal antibody durvalumab (Imfinzi), used in adults with certain types of biliary tract cancers, also has a biosimilar product currently in development, InVivoSIM anti-human PD-L1 (durvalumab biosimilar).²³

In addition, a biosimilar is under review for atezolizumab (Tecentriq), a monoclonal antibody used to treat urothelial carcinoma, non–small cell lung cancer, and small cell lung cancer, among other cancers.²⁴

Looking Toward the Future of Biosimilars

Global cancer cases are expected to rise by 77% by 2050, reaching 35 million cases.²⁵ As the use of oncology biosimilars increases, these affordable alternatives to the biologic reference drugs may lessen the financial impact on patients and payers. Pharmacists must stay current on the fast-moving biosimilar landscape as these new therapies come to market.

References

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