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