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Research Round Up: Biosimilar Medications are Safe and Effective

Biologics are drugs derived from living organisms and are used to treat a variety of complex chronic diseases, including rheumatoid arthritis,1 inflammatory bowel disease,2 and certain cancers.3,4 Similar to generics, biosimilars are versions of brand “reference” biologics already approved by the FDA.5 Despite their demonstrated safety, efficacy, and lower price tags (they are projected to save U.S. patients, taxpayers, and health care systems over $180 billion between 2022 – 2027 6), biosimilars have faced significant hurdles in approval, market entry, and adoption in the United States.

One such hurdle is the burdensome evidentiary standards required for interchangeability. Interchangeability is a regulatory designation which allows a biosimilar to be substituted for the reference biologic by a pharmacist – in the same way as generics – without the prescriber’s intervention.

Another hurdle is continued misinformation about the safety and efficacy of biosimilars aimed at providers and patients. This misinformation has led some patients to express concern about their use. Perverse financial incentives pose additional barriers to more widespread adoption of biosimilars.

Leveraging our integrated model, Kaiser Permanente has been a leader in biosimilar adoption. Several factors contribute to our success including:

• Strong prescriber confidence in our drug formulary, which is evidence-based and developed in partnership by our expert pharmacists and Permanente Medical Group physicians;

• A commitment to generating and disseminating unbiased information to educate clinicians and patients; and

• Evidence-based prescribing practices that are not influenced by drug reimbursement.

You can learn more about our success and adoption rates in the brief Biosimilars at Kaiser Permanente.

Kaiser Permanente has leveraged its widespread adoption of biosimilars to conduct pharmacy outcomes research that explores key questions:

1. Are biosimilars as safe and effective as their reference biologics?

2. Are patients comfortable being prescribed a biosimilar?

3. Is the biosimilar interchangeability designation necessary?

Original research from Kaiser Permanente has demonstrated the safety and effectiveness of biosimilars

In addition to achieving high rates of biosimilar adoption, Kaiser Permanente is committed to the ongoing and extensive review of real-world patient outcomes. Our researchers have conducted pharmacovigilance and comparative effectiveness studies that have repeatedly found biosimilars to be safe and effective options, not only in comparison to the reference biologic but also when compared to other biosimilars. For example:

• Among patients with lymphoma, there were similar rates of survival, overall response, and side effects with the biosimilar Truxima versus the reference biologic Rituxan7

• Patients with metastatic colorectal cancer treated with either the biosimilar Mvasi or the reference biologic Avastin experienced no differences in overall survival or serious side effects8

• Among patients on chemotherapy taking either Zarxio or Nivestym, which are both biosimilars of the biologic Neupogen, there was no difference in rates of severe immunosuppression or infection9

• For patients with inflammatory bowel disease who switched from the reference biologic Remicade to the biosimilar Inflectra, there was no increased risk of disease worsening compared to those who remained on Remicade10

Kaiser Permanente researchers have also studied patient perceptions after switching from a reference biologic to a biosimilar.11,12 Among surveyed patients with arthritis who switched from Humira to the biosimilar Amjevita, respondents were satisfied with factors such as disease control, side effects, access to information regarding safety and efficacy, and cost.

Policy Opportunities

Based on the current body of literature and internal discussions among Kaiser Permanente pharmacists and providers, we recommend several ways policymakers can bridge the gap in biosimilar adoption:

1. Eliminate the interchangeability standard for biosimilars. This regulatory designation, which does not exist in Europe, creates confusion and the perception that biosimilars without interchangeability status are inferior. Recent studies and official FDA statements have overwhelmingly supported the safety and effectiveness of biosimilars when directly compared to reference biologics. Policymakers should eliminate the interchangeability designation, or otherwise deem all biosimilars as interchangeable, and allow pharmacist substitution of biosimilars.

2. Promote unbiased information about biosimilars. There are few unbiased resources about biosimilars readily available to prescribers to counter a misleading narrative that biosimilars are inferior to reference biologics. Kaiser Permanente researchers have contributed to the body of evidence that biosimilars are safe and effective, and that patients have a positive perception. However, misinformation and pharmaceutical marketing targeted at patients and prescribers continues to erode patient and provider confidence. Policymakers can help bridge this gap and foster confidence in biosimilars by increasing access to clinical data and unbiased educational resources.

3. Bolster operational and financial incentives for biosimilars. Converting patients to biosimilars from reference biologics and overcoming other operational barriers to using biosimilars can be resource-intensive. Policymakers may need to provide temporary support to encourage providers to take these steps until a greater level of expertise with biosimilars is achieved. For example, lawmakers should consider preserving the temporary increase in the Medicare Part B payment for certain qualifying biosimilars, which is set to expire in 2027. Additionally, insufficient or perverse payment incentives that encourage providers and health plans to prefer pricier biologics over biosimilars should be examined and addressed.

4. Examine anti-competitive practices in the biologics market. Patents are important catalysts for innovation. However, manufacturers use hundreds of patents and pay-for-delay agreements to block biosimilar competition and maintain high prices far longer than our patent laws intend.  These anticompetitive practices should be examined and addressed.

References

1. Aletaha D, Smolen JS. Diagnosis and Management of Rheumatoid Arthritis: A Review. JAMA. 2018;320(13):1360-1372. doi:10.1001/jama.2018.13103
2. Jiang Y, Chen Y, Yu Q, Shi Y. Biologic and Small-Molecule Therapies for Moderate-to-Severe Psoriasis: Focus on Psoriasis Comorbidities. BioDrugs. 2023;37(1):35-55. doi:10.1007/s40259-022-00569-z
3. Baumgart DC, Le Berre C. Newer Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. N Engl J Med. 2021;385(14):1302-1315. doi:10.1056/NEJMra1907607
4. Hernandez R, Põder J, LaPorte KM, Malek TR. Engineering IL-2 for immunotherapy of autoimmunity and cancer. Nat Rev Immunol. 2022;22(10):614-628. doi:10.1038/s41577-022-00680-w
5. Maiuthed A, Chantarawong W, Chanvorachote P. Lung Cancer Stem Cells and Cancer Stem Cell-targeting Natural Compounds. Anticancer Res. 2018;38(7):3797-3809. doi:10.21873/anticanres.12663
6. “Biosimilars in the United States 2023–2027,” The IQVIA Institute for Human Data Science, January 31, 2023. |
7. de Mora F. Biosimilars: A Value Proposition. BioDrugs. 2019;33(4):353-356. doi:10.1007/s40259-019-00360-7
8. 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.2022.8880
9. Wong HW, Nguyen VH, Mok TY, et al. Outcomes of Rituximab-abbs versus Rituximab in Patients with Diffuse Large B-Cell Lymphoma in a Noninferiority Study. BioDrugs. 2024;38(4):601-610. doi:10.1007/s40259-024-00666-1
10. Pham C, Niu F, Delate T, et al. Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer. BioDrugs. 2023;37(6):891-899. doi:10.1007/s40259-023-00624-3
11. Lee YJ, Delate T, Hui RL, Le K, Pham C. Real-World Noninferiority Assessment of Two Filgrastim Biosimilars in Patients Receiving Myelosuppressive Chemotherapy. JCO Oncol Pract. Published online July 24, 2024. doi:10.1200/OP.24.00047
12. Ho SL, Niu F, Pola S, Velayos FS, Ning X, Hui RL. Effectiveness of Switching from Reference Product Infliximab to Infliximab-Dyyb in Patients with Inflammatory Bowel Disease in an Integrated Healthcare System in the United States: A Retrospective, Propensity Score-Matched, Non-Inferiority Cohort Study [published correction appears in BioDrugs. 2020 Jun;34(3):405. doi: 10.1007/s40259-020-00423-0]. BioDrugs. 2020;34(3):395-404. doi:10.1007/s40259-020-00409-y
13. Pham C, Niu F, Hui RL, Le KN, Delate T. Patient perceptions on switching from reference product adalimumab to biosimilar adalimumab-atto. Clin Rheumatol. 2024;43(3):1269-1270. doi:10.1007/s10067-023-06822-2

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