Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: Similarities and differences of biosimilars versus the original product—that’s a great question to look at. We’re looking at differences between a brand-name product and another product, just in terms of clinical trials. Our main focus has always been to look at the differences, right? That’s been our goal. One is better than the other. One is actually superior than the other in terms of treatment.
That doesn’t fall into the same view or equity when we’re taking with the biosimilar from a patient. In fact, we have to switch that. We have to say that these 2 drug therapies—a biologic is a brand-name product; the biosimilars are also a biologic—will have similar outcomes in terms of safety and efficacy and also outcomes for the therapeutic indications. So we’re looking at that patient-sensitive population.
In many cases we may see some small variations, but the overall FDA approval process looks for compelling evidence. What that means is we take the preclinical, the analytical, the phase 1—based pharmacokinetic and pharmacodynamic activity, and the immunogenicity profile—on top of that phase 3 study that this was actually studied in—to address the actual FDA indication.
When we take a look at the sensitive populations, we look for a similar efficacy profile for that patient on the actual brand-name therapy versus the biosimilar. Therefore, we’re not looking so much at differences; we’re looking at similarity. That’s when the whole package for approval comes into place, and that’s for a biosimilar. We’re often tainted with the idea that we have to make a difference in outcomes, when in truth we’re looking for similarity in outcomes, both from the actual adverse effect profile and the safety profile itself.
Kashyap Patel, MD: Biologics and biosimilars are pretty identical as far as their safety and efficacy are concerned, and that’s one of the reasons why the FDA has allowed parent compounds of the reference molecule to be approved in multiple indications. The biosimilar does not have to undergo studies in all indications. Once a biosimilar is approved on a specific study, it can be extrapolated where it will have the same efficacy in all the other indication that the FDA has approved the parent compound for.
In my experienced opinion, outside the manufacturing process, as far as structural variance is concerned, as far as efficacy is concerned and safety is concerned, biosimilars are identical to the referenced biologic.
Ali McBride, PharmD, MS, BCOP, FAzPA, FASHP: How do the dosing variations compare with the biologic and biosimilars? When we’re taking a look at these, the biggest thing we’re looking at is the safety and efficacy profile. But there can be some variation on how that drug is distributed. For many of us, we can find out, for example, that with one biosimilar, it comes only in the syringe. Even though the original biologic product had the availability of, for example, a vial and a syringe to be given for smaller dose in certain patient populations. In those cases we may have some variations based on usage. In other cases, we may actually the availability of a single-dose vial versus a multidose vial.
For example, there’s another biosimilar out there that was just recently approved that will see multidose vials. What that does is it allows us to conserve and reduce drug waste. In terms of the availability of how that drug is administered for the biosimilar versus biologic, that may lead to 1 preference or another. In some cases, those numbers may be very small for utilization of that administered dose.
When we take a look at storage facilities and look at temperature storage, that may have an impact based on facility site. For example, you may not have enough space in your refrigerator or your inventory area. We may actually have a certain compound of products—you can withdraw those out—which may also be limited. Any type of facility that can implement either extended storage, or a cold, sensitive product. We’re look at cold-chain supply, and these product lines may actually help configure what the best biosimilar or brand-name product is.
Usually they follow similar types of rationale between them. It’s not often a consideration, but if we’re taking a look at available product—which may actually come in a multidose vial and may automatically lapse—we may say, “Hey, this is a great biosimilar. Let’s choose this because it decreases the overall drug waste, which may be an issue or consideration when we take a look at these patients.”