First came biologics, then biosimilars. And soon, explains a newly released video from The Alliance for Patient Access, patients can expect interchangeable biosimilars.
According to the FDA, these therapies will be so like their reference products that pharmacists can dispense them instead of a prescribed biologic. The agency describes interchangeable biosimilars as imitations that offer a nearly identical benefit as the original biologic for “any given patient.”
That’s a big promise, the AfPA video acknowledges. So how can the FDA be sure?
The agency’s recent draft guidance on interchangeability offers a glimpse into regulators’ thinking. Exact data requirements may vary by product, the document explains, and manufacturers should communicate with the FDA about how best to demonstrate interchangeability. Yet several requirements seem certain:
- Clinical trials on the biosimilar
- Information about its biochemical make-up
- Details about its impact on patients’ immune systems
- Data on switching.
This last component is crucial, AfPA’s video argues. Patients who take a biologic or biosimilar regularly over a period of time depend upon an expected response. To date, the body of research on patients’ response to switching among biologics and biosimilars is limited. Yet the cost savings expected from biosimilars makes switching – either voluntary or imposed by health plans – likely.
FDA’s guidance requires data from “one or more switching studies.” These are clinical trials designed to demonstrate that patients are not worse off when switching than when staying on the original medication. But AfPA points to a critical and missing detail from FDA’s guidance. For a biologic that treats several different diseases, will switching data be required for each disease? If not, how dependable can the interchangeability promise be?
The video advocates for a “cautious approach” that requires “comprehensive switching study requirements.” This approach can maintain the FDA’s track record of safety and efficacy, the video concludes, ensuring that interchangeable biosimilars work for the patients who need them.
To learn more, watch “The Interchangeability Promise.”