When Should Biosimilars Be Used?

There is no clinically meaningful difference between a biological product and its reference product in terms of safety, purity, and potency. However, the effects of switching to a biosimilar among certain patient populations is still unknown, as was discussed at today’s Advances in Inflammatory Bowel Disease Regional Meeting in Los Angeles, California.

Christina Y. Ha, MD, from Cedars-Sinai Medical Center in Santa Monica, California, outlined the definitions and requirements of biosimilars as well as which patient populations can safely switch to one in her presentation, “Biosimilars for IBD: Start, Switch or Stay Away.” 

First, demonstrating biosimilarity is a 3-step process, according to Ha: the pharmacokinetics and pharmacodynamics must be evaluated; the clinical efficacy, safety, and immunogenicity relative to reference product must be demonstrated, and pharmacovigilance must be performed.

“How should we use this in our practice? When we are talking about positioning—because we have so many options nowadays to treat ulcerative colitis—how do we use the biosimilars?,” said Ha. “It is very important for yourself and your patients that they are positioned in the exact same place as branded infliximab. They are not a new mechanism of action, not a new anti-TNF, it is a biosimilar to infliximab, so it is the same positioning as the originator products.”

Thus, so long as the biosimilar has the same strength, dosage form, and route of administration as the reference product, individuals with IBD who have newly started infliximab or are resuming infliximab after prior drug holiday, can safely switch to a biosimilar, according to Ha.

While individuals in stable remission on infliximab would not jeopardize their outcomes, levels, or immunogenicity if they were to switch to a biosimilar, it is unknown whether the switch would be as safe among individuals with active disease because the effect on their pharmacokinetics, immunogenicity, and efficacy is not understood.

Ha also said that she would not switch her patients to a biosimilar if active disease is present, if there is high risk for disease flare, or if the patient has a high-risk condition, such as pregnancy.

Further, interchangeability should be expected more often in clinical practice.

“Interchangeability may be reasonable if it is cost-effective based on current data, but only for patients who are in sustained remission or stable dosing,” said Ha.

—Colleen Murphy

Reference:

Ha C. Biosimilars for IBD: Start, Switch or Stay Away?. Paper presented at: Advances in Inflammatory Bowel Disease Regionals. April 6, 2019; Los Angeles, CA. 

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