Biosimilars vs Originators: Providers May Be Mislead Due to Research’s Margin of Error
The wide range of margin of error in clinical trials may mislead health care providers into prescribing biosimilars over originators, and vice versa, according to a new review.
To better understand the margin of error among clinical trials, the researchers performed a systemic review of online databases from inception to February 17, 2017. Four trials were included in the review, which included 1746 patients aged 18 or older, had a diagnosis of plaque psoriasis, and were randomly assigned to receive a biosimilar or an originator.
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Psoriasis Area and Severity Index (PASI) scores were assessed at week 12 or later.
Analysis showed that the margin of error among these trials ranged from ±14% to ±18%, which may be viewed as “unacceptably wide” or “imprecise” to health care providers.
“One physician might consider these parameters sufficient and comfortably prescribe the biosimilar as a replacement for the originator; however, another clinician might require more conservative margins,” the researchers wrote.
“As biosimilar approvals accrue and their use increases, possibly delivering decreased healthcare costs and better patient access, practitioners require a deeper understanding of the design and conduct of clinical trials to better interpret the true likelihood of achieving the same clinical outcome regardless of drug choice,” the researchers concluded.
—Christina Vogt
Reference:
Wan MT, Strober BE, Wu JJ, Shin DB, Gelfand JM. How similar are the treatment responses to biosimilars in patients with psoriasis? A systematic review of statistical margins in comparative clinical trials. J Am Acad Dermatol. 2017;77(3):569-572. doi: http://dx.doi.org/10.1016/j.jaad.2017.05.032.