Non-Medical Switching of Biosimilars and Generics


An expert in dermatology discusses the potential impact of non-medical switching to biosimilars and generic formulations on safety and efficacy profiles.

Adam Friedman, MD, FAAD: When we start to think about nonmedical switching for biologics—and we have seen the emergence of some biosimilars—some questions certainly have to be raised. If you jump from 1 to the other, are you going to have the same exact effect? The answer, from everything we know, which is somewhat limited but growing, is that that is not the case. Personally, I have not been a victim of this, nor my patients as of yet, because the majority of the biosimilars that are available to us are of older biologics in the world of psoriasis. I find myself using newer generations such as IL-17 or IL-23 blockers, for which we do not have biosimilars.

Fortunately, I have not really suffered at the hand of this nonmedical switching. But what we do know, even outside the dermatology world—in rheumatology or possibly even with inflammatory bowel disease—is that these are not created equally. It is also important to note that generics and biosimilars aren’t interchangeable; that language is not interchangeable in terms of what metrics must be met for 1 of these alternatives to receive FDA approval. From what I’ve heard outside dermatology and from peers, this can be exceedingly disabling. But when we think about biologics in particular, the risk of developing neutralizing antibodies—meaning this kind of switching back and forth—increases. The likelihood that someone is going to develop an immune response that will really affect this medication’s ability to do anything actually goes up. Forget the efficacy, forget the baseline safety. One of our concerns when using this medication is actually amplified when you jump around. In dermatology, even though many of us may not have experienced this yet, it is coming, and we must be prepared for it.

With nonmedical switching, there is definitely a good chance for diminished impact or efficacy. This comes in a couple of different flavors. When we think about topical agents, for example, we are always so focused on the active ingredient—whether it’s a steroid, a calcineurin inhibitor, a retinoid, you name it. It is not always just about the active ingredient, for which there are trade and generic, but also about the vehicle, which plays a big role in how a medication will work. When thinking about trade vs generic, the vehicle is not part of that package; it’s just the active ingredient. The generic may be delivered in a vehicle that does not penetrate as well, that does not interface with the skin as well, or that may have ingredients that could be irritating. 

That can affect efficacy overall. Saying that you are going to switch from a trade to a generic form of the same active ingredient is really saying that there could be 2 different drugs in terms of how it behaves on different skin types, in different locations of the body, and with different disease states. Taking a step up in terms of biologics, we have to consider that biosimilars are just that: They may be similar, but they are not the original. Certainly we have to anticipate that they will behave differently in different patients. What it comes down to is that we just need more research; we need to know 1 way or another what happens when you go back and forth. This is a call to action. We should not wait for this to become a bigger problem. We want to know what is going to happen and have the data ready, so we can argue and fight back when this happens to our patients. A lot of these decisions are theoretically data driven, so if we do not have the resources or the data, that makes it much harder for us. I’ll be honest: It is most important for our teams, who were working tirelessly to get these approvals and fight with prior authorizations and for us. A lack of data makes it a lot harder for us to make our point.

Transcript Edited for Clarity

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