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“Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo.
The first FDA-approved biosimilar to become available in the U.S. is Inflectra (infliximab-dyyb), a biosimilar to Remicade (infliximab). Thus, patient awareness of biosimilar drugs is not commonplace yet. However, that will likely change in the future as more biosimilars are approved for use.
“Patients are likely to start having questions about biosimilars just as rheumatologists started asking questions a few years ago in anticipation of their arrival,” says Dr. Huston. Patient questions that will likely arise about biosimilars—and possible answers—include:
What is a biosimilar?
Possible answer: The U.S. Food and Drug Administration (FDA) says, “A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.”
Are biosimilars generic versions of biologics?
Possible answer: No, they are not the same. “Biosimilars are not generics, which are ‘replicas’ of the branded drug,” says Ellen Field, MD, Lehigh Valley Health Network, Bethlehem, Pa.
Dr. Huston explains that biologics and biosimilars are large, complex molecules created in living systems. “Their effectiveness and safety are directly related to their three-dimensional structure, which can be altered by many factors in the manufacturing process,” he says. “It is, therefore, impossible to make an exact copy of a biologic drug, unlike the situation for traditional generics, which are much simpler from a chemistry perspective.”
Is a biosimilar as safe and effective as the reference compound?
Possible answer: The FDA has approved biosimilar drugs, and will likely approve more, because they are believed to be safe and effective. Research is ongoing. Dr. Field says, “I believe the rheumatology community is willing to consider biosimilars for their patients if studies substantiate the safety and efficacy profiles are very similar to the parent compound and [if the biosimilar] is the best treatment option for them and their lifestyle.”
Rheumatologists want to have confidence telling patients it is okay to take a biosimilar, but most are opposed to mandatory medication switching of stable patients by insurance companies or pharmacies, Dr. Huston says. This could become an issue if insurance companies advocate switching medications or if patients are looking to change from a biologic to a biosimilar due to cost.