What about extrapolation of data so a biosimilar can be approved for the same indications as its reference product? That’s one unknown that concerns some rheumatologists, said Dr. White. The ACR is closely engaged with the FDA to ensure that “clinical data from one population of patients are not extrapolated to another patient population, thus allowing FDA approval in an untested population without great caution,” he said.
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Explore This IssueApril 2016
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Although the FDA’s biosimilar pathway allows for clinical data to be extrapolated to additional indications, applicants will still need to provide adequate scientific justification for doing so, said Dr. Christi.
To give prescribers accessible information about these new drugs’ designations and indications, the FDA has published an online reference, The Purple Book, which lists licensed biologics with reference product exclusivity, and under these, the biosimilars and interchangeables for them.
Control & Tracking
Clear communication and naming of these drugs will help rheumatologists and others track efficacy, said Dr. Daikh.
Without distinct naming, “it will be difficult to tell if a patient has been switched, and to sort out whether a clinical change resulted from such a switch. It will also be impossible to track aggregate experience with the drugs, such as through adverse drug event reporting, to learn about potential safety signals with these agents,” he said.
No applications have been made yet for interchangeables, but pharmacists would be able to substitute these drugs for the reference biologic without notifying the prescriber. Seventeen states passed laws to require notification anyway, and more are considering legislation.
Pharmacists want to lower costs, streamline fulfillment and work with prescribers to ensure safety, said Bernadette Eichelberger, PharmD, program director of the Academy of Managed Care Pharmacy’s Biologics and Biosimilars Collective Intelligence Consortium. This research network was founded in 2015 to conduct analyses on biosimilars and their reference biologics, using data collected from managed care organizations, pharmacy benefit managers and physicians.
“Our job is to ensure that when these drugs come to market, they are being monitored,” said Dr. Eichelberger. “If we don’t have active surveillance of these products, it puts patients at risk.”
Some patients may be required to take a biosimilar by their insurer if they’re prescribed a biologic that has one, said Mr. Eich. Rheumatologists will still have treatment options.
“Even in that instance, you will ideally have a significant clinical choice as to which biologic to use,” said Mr. Eich. “You may still maintain the decision rights around which product you prescribe.” However, a right to prescribe a product, does not mean that the insurer can’t insist on switching to a formulary biosimilar.