Discussing Biosimilars With Patients

Consulting with patients is a key consideration when prescribing biosimilars. It is important that patients are confident in the safety, efficacy and quality of their medicines. Healthcare professionals can discuss the lack of clinically meaningful differences between biosimilars and reference biologics to educate patients on the value and reliability of the treatment.

What Patients Need To Know

When educating patients about the biosimilar options available to them there are four key points to share:


Like reference biologics, biosimilars are carefully evaluated by regulatory authorities1


Biosimilars are scientifically proven to be highly similar to reference biologics with no clinically meaningful differences in safety and efficacy2


Biosimilars can provide patients with more treatment options


Biosimilars require scientific expertise and experience to develop and manufacture3

Carefully Evaluated

Regulatory bodies, like the US FDA, require that the manufacturer demonstrate similarity of the biosimilar with the reference product with respect to quality, safety, and efficacy as the reference biologic.2 This includes:

  • Data, studies, and tests
  • Ongoing safety monitoring
  • Regular quality checks of where and how a biosimilar is made.

Proven Similarity

Regulatory bodies like the U.S. FDA require that all biosimilars undergo rigorous regulatory review to ensure the biosimilar is highly similar to the reference biologic, and there are no meaningful clinical differences between the biosimilar and the reference biologic.2 This includes:

  • Same benefits
  • Same strength and dosing
  • Same route of administration
  • Same possible side effects

More Choice

Biosimilars provide patients with choices that can meet their needs. More choices mean more benefits, including:

  • More treatment options3
  • Potentially lower costs4
  • Increased competition among medicines4

Expertise and Experience

Patients may gain confidence in a biosimilar prescription once they understand that all biosimilars are required by stringent regulatory bodies, such as the U.S. FDA, to be:

  • Developed with scientific expertise
  • Supplied by manufacturers with proven manufacturing capabilities

Additional Resources for Patients

In addition to the above information, patients may want additional information about biosimilars. The links below can be shared to further educate patients and increase their confidence in the treatment prescribed.


  1. Vulto-Jasquez. Rheumatology. 2017;56:iv14-iv29.
  2. USFDA. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product. 2015.
  3. USFDA. Biosimilar and Interchangeable Biologics. More Treatment Choices, 2021.
  4. IQVIA. IQVIA Biosimilars In the United States.URL: https://www.iqvia.com/-/media/iqvia/pdfs/institute-reports/iqvia-institute-biosimilars-in-the-united-states.pdf. Accessed August 2022.