Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA), discusses the history and controversy behind 4-letter suffixes used for biosimilars.
The Center for Biosimilars® (CfB): Hello, I'm Matthew Gavidia. Today on the MJH Life Sciences Medical World News, The Center for Biosimilars® is pleased to welcome Nancy Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA). Can you just introduce yourself and tell us a little bit about your current role at ACMA?
Globus: Sure. I'm a pharmacist by trade, and I've spent almost 20 years working with the industry to prevent medication errors and to build safety and error prevention into their products. I mostly evaluate [product] names to prevent name confusion and I also evaluate label and product designs. So, it's very much a lot of the things that the DMEPA [Division of Medication Error Prevention and Analysis] group at the FDA does, but I provide those services for pharmaceutical company clients.
CfB: Can you explain what a biosimilar name suffix is and your role in helping companies choose the suffixes and the brand names?
Globus: Sure. So, a biosimilar suffix is a 4-letter string of lowercase letters, that should be meaningless, that are attached to the nonproprietary name for the product. So, if we were talking about small molecules, it would be the generic name. But since these are biologics and not generics, we use the nonproprietary. And the reason for having a suffix is to distinguish the products, because biosimilar products need to be grouped together to avoid product selection errors. So, we need to know, if it's an infliximab product for instance, which infliximab product it is. They need to be grouped together but still distinct so that adverse events and any postmarketing safety signals can be tracked.
CfB: Suffixes for biosimilars have been somewhat controversial. What is the importance of suffixes when it comes to accurate prescribing and pharmacovigilance?
Globus: So, again, it's really for accurate prescribing. It's for making sure that the products are grouped together, but still distinct, and that they can be tracked accurately from not only an error standpoint but also for the tracking of adverse events.
CfB: Can you explain why there has been opposition to adding suffixes to biosimilar names?
Globus: It's really interesting, because it depends on whose perspective you're looking at. The patient advocacy groups just wanted to cut out the red tape and increase patient access to the products. The innovator companies wanted to maintain their patent exclusivity. And the biosimilar companies want their products to be viewed as clinically [similar] to the innovator products, which they are. So, everybody's got a different piece of the pie and a different stake in the procedure.
CfB: The FDA has gone through a certain amount of evolution in its thinking on how suffixes should be applied to biosimilars, originator products, and interchangeable biosimilars. Can you take us through the history from the US regulatory standpoint?
Globus: Sure. So, in August 2015, a draft guidance was introduced by the FDA that set the framework for what a biosimilar suffix should be and what it should not be. It should be 4 letters, meaning lists should not cause any additional confusion. Also, in that guidance they stated that they were going to retrospectively add these 4-letter suffixes to innovator biologics that had already been on the market, and that was really what caused most of the controversy. The draft guidance came out in August of 2015. It was finalized in January of 2017.
Meanwhile, in the background, biosimilar products were getting approved without a firm decision on what the naming framework was going to be. As the controversy continued, the biggest issue was applying suffixes retrospectively. There was pressure from patient groups, payers, [and] different sectors of the industry, all playing into this.
So, in March of 2019, [the FDA] reversed their decision and said that suffixes were not going to be applied retrospectively. New innovator products and biosimilars would have a suffix, but originator biologics that were already on the market would not.
CfB: And to build on top of that, as you just alluded to, since the March 2019 guidance from the FDA, things appear to be changing yet again. Can you speak more on this and on what the implications might be?
Globus: So, I think the biggest change since then has been in March 2020 that marked the end of a 10-year transition period where some biologic products, such as insulins and growth hormones, were being transitioned from a drug regulatory pathway to a biologic regulatory pathway.
Also, suffixes were not applied retrospectively to those transition products, but new products that are being approved would have a suffix attached. And we saw this as evidenced in the recent approval of Eli Lilly's Lyumjev, which is an insulin product that has a 4-letter suffix attached to the nonproprietary name.
CfB: How well do you think the current guidance and policy on suffixes fits with industry and medical needs?
Globus: I think it's good. I think with all of that back and forth negotiation, that everybody got something out of it. I think it's a good balance. The innovator manufacturers didn't have to apply suffixes retrospectively. And it does provide a good framework, not only for identifying products and preventing product selection errors, but also for tracking from a drug safety and pharmacovigilance aspect.
CfB: How about the direction things appear to be going now?
Globus: I think one thing that I would like to see, and it's definitely being worked on, is an increased awareness of what the regulations are, just because people become more familiar with biosimilars when they have more access to them, and as uptake and acceptance of the concept as a whole increases. Especially on the industry side, if someone hasn't gone through a branding and naming exercise in the past, there's a lot of nuances there. So, I think an awareness of what the regulations are is going to drive along changes.
I think that the first biosimilar that was approved with the suffix that was indicative of the license holder, Zarxio [filgrastim-smdz], still sticks in people's minds. But it's a nonproprietary name; it's not supposed to be suggestive of anything. And likewise, it also can't be confused with anything. We certainly don't want the addition of that 4-letter suffix to be confused with any other abbreviation that's used in the prescribing of the drugs. And that's really what I do, being a medication error prevention expert that's looking at where those errors happen, how they happen, and how we can avoid them.
To read a recent column by Globus on biosimilar naming issues, click here.