Biosimilar considerations for prescribers

Key takeaways:
  • Equipped with proper education, providers can recognize and dispel myths and misinformation1
  • Patients should know:

Biosimilars are as safe and effective as the originator biologic2

They are thoroughly evaluated by the FDA2

They can provide more treatment options—and potentially lower costs2

Providers should be prepared to provide education about biosimilars

Providers and patients face a good deal of misinformation about biosimilars, and it’s important that they’re armed with resources that can dispel certain misleading or untrue information about biosimilars.1

The concept of “biosimilarity” can cause confusion, because the word “similar” implies that there is a difference of some sort. It’s important to note that while the natural source of biosimilars leads to inherent variation (i.e., small changes to the protein molecule),3 all biosimilars must be proven to have no clinically meaningful differences in safety or efficacy from the original biologic.2

The FDA’s evaluation process ensures that all biosimilar products meet the FDA’s high standards for approval.2

Also, the fact that biosimilars are not put through as many clinical studies as their originator biologics could lead to similar concerns around safety and efficacy. While the clinical data package supporting biosimilar approval is more streamlined compared to the originator biologic, Providers can make known that the overall data package is equally rigorous. The FDA can request a biosimilar manufacturer to conduct additional studies prior to granting approval if they are not convinced of the comparability.1

Each originator biologic is assigned a 4-letter suffix at the end of its generic name. A biosimilar will carry the same generic name but will have its own unique suffix. This is required to differentiate it from its originator biologic and clearly identify it to promote pharmacovigilance.4 It does not mean there are safety or efficacy differences between the products.5

What is Interchangeability?

Questions also remain around the concept of interchangeability.
This is a status granted to a biosimilar that has undergone additional studies so that it may be substituted at the pharmacy for the originator biologic without the intervention of the prescribing health care provider—much like how generic drugs are routinely substituted for brand-name drugs.

Companies must submit an application with adequate information to support an interchangeability determination for their product to be approved as an interchangeable biosimilar.6

While this designation provides liability protection to pharmacists, it merely permits switching between products as needed. Interchangeability is not a necessity for a biosimilar to be prescribed. The necessary FDA review process already ensures that the biosimilar has no clinically meaningful differences from its originator biologic and demonstrates comparable safety and efficacy.2

A 2020 study supported by the Education Committee of the Biosimilars Forum details how providers also must combat the following forms of biosimilar disparagement and misinformation1:

  • Statements about biosimilar science or policy that are factually incorrect.
    • These include the notion that pharmacovigilance monitoring of biosimilars is inadequate and patients cannot
      be confident about the reliability of these data, leading to unwarranted concerns over safety.1
    • It’s important to note that biosimilars are required to maintain the same rigorous reporting and monitoring as the originator.1
    • The 4-digit suffix is a mechanism to report information about a specific product.5
  • Incomplete information, where only partial or a limited set of facts are provided.
    • Statements noting that biosimilars are not identical to their originator biologics are common, stemming from 
      confusion like the examples outlined.1
    • These statements omit certain facts and are intended to mislead. While there are inherently small differences between batches as a natural part of the manufacturing process, they do not impact a biosimilar’s safety and efficacy.1
    • Before approving a biosimilar, FDA experts must conclude it is highly similar to—and has no clinically 
      meaningful differences from—the original biologic with regard to safety and efficacy.2
Biosimilar disparagement and misinformation has a very real potential to slow adoption of biosimilars, diminishing opportunities to increase patient access and reduce drug costs. Ultimately, patients want to trust their providers, who exhibit great influence over the treatments their patients receive. Provider guidance on biosimilars is critically important to educating that biosimilars are as safe and effective as their originator biologics and may be able to provide access to patients in need.1

Ultimately, patients should be made aware that:

  • Biosimilars are safe and effective.
    • Biosimilars are as safe and effective as the originator, or biologic, drugs they are based on.2
  • They are thoroughly evaluated by the FDA.
    • Before approving a biosimilar, FDA experts must conclude it is highly similar to—and has no clinically meaningful differences from—the original biologic. The FDA’s evaluation process ensures that all biosimilar products meet the FDA’s high standards for approval.2
  • They can provide patients with more options—and potentially lower costs.
    • Biosimilars that have entered the U.S market have launched with initial list prices anywhere from 15% to 35% lower than their biologic competitors.8
    • As biosimilars offer additional treatment options for patients, biologics manufacturers could be inclined to lower the cost of their drugs, the originators, to compete, and this competition could ultimately result in reduced drug costs.9


The concept of switching patients from originator drugs to biosimilars—and from a biosimilar to a different biosimilar—has also generated a great deal of discussion. Fears exist among providers that moving a patient to a biosimilar presents some kind of inherent risk because biosimilars contain variation as part of their manufacturing process.10 But it’s again important to note that FDA-required studies go to great lengths to ensure there are no clinically meaningful differences between biosimilars and their originator biologics, and that they are both safe and effective.2

Learn more about the key considerations for biosimilars with each of the following groups.


Specialty Pharmacies

To learn more about the promise of biosimilars, the impact they can create, and our work in this space, visit the following pages:

1. Cohen H, McCabe D. The importance of countering biosimilar disparagement and misinformation. BioDrugs 2020;34(4):407-414.
2. Biosimilar and interchangeable biologics: More treatment choices. U.S. Food and Drug Administration. October 12, 2021.
3. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19(3):411-419.
4. What’s in a biologic or biosimilar name? Biologics Suffix. 2019.
5. Suffix vs no suffix: Naming biologics and biosimilars. Biosimilars Council. 2019.
6. Interchangeable biological products – U.S. food and drug administration. U.S. FDA.
7. Bridges L, White DW, Worthing AB, et al. The science behind biosimilars. Arthritis & Rheumatology. February 7, 2018. Accessed June 28, 2023.
8. Decreasing drug costs through generics and Biosimilars. National Conference of State Legislatures. Published January 21, 2022.
9. Biosimilars in the United States 2023-2027. IQVIA. Published January 31, 2023.
10. Cohen HP, Blauvelt A, et al. Switching reference medicines to biosimilars: A systematic literature review of clinical outcomes. Drugs 2018;78:463–478.