Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA), discusses the truth behind 4-letter suffixes and product confusion among physicians and pharmacists.
To watch Part 1 of this interview, click here.
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).
How has the industry responded to the status quo and existing guidance? What are you hearing from the biosimilar development community?
Globus: Again, I think certainly the bigger companies that have a huge stake in this, such as innovator companies with their own biosimilar arms, [have adapted]. I think some of the smaller companies need some guidance and outside expertise to assist with creating the awareness [of what regulations exist]. Again, it's all about the uptake of the biosimilar concept as a whole. And I'm sure you see it that way, too, being an information provider of biosimilar information to not only the industry but to the prescribers and patients as well.
CfB: Has there been any evidence suggesting that suffixes add to confusion at the pharmacy counter?
Globus: So, it's really interesting because we have to remember that medication errors are caused by a confluence of a number of issues. The name is only 1 of those issues that could cause confusion or error. There are practitioner and practice site—related issues, and on the industry side, we're just talking about the nonproprietary name. The brand name and what the package looks like could be a cause of confusion, too.
So, we have to remember that there are a lot of causes of medication errors, including the fact that medication error reporting is voluntary. Maybe somebody is confused by something but because it was a near miss, they don't think to report it. So, it's very difficult to get hard evidence on the occurrence of errors. It's very much dependent on practitioner reporting. Also, if any of those product complaints that go to the industry get coded as a medication error rather than just an adverse event, they have to be turned into a signal that's actionable.
CfB: And to build on that, is there any evidence that physicians and pharmacists aren't keeping track of which biosimilars are being used?
Globus: That also is an interesting topic, and it depends on the clinical setting. I know when I was a hospital pharmacist, we had a therapeutic interchange, which allowed for substitution of one product for another without physician intervention or prescriber intervention. But those decisions are made at a policy level of the institution. So, somebody has to sign off on it somewhere; it's just that it gives the pharmacist the latitude to dispense per policy. It's an interesting aspect. And I think also again, there are many sides of this story where there's pressure from payers which branded product is going to get paid for and you have patients that need to get whatever product [they're using] and have it covered. It's very complex.
CfB: Different than the United States, Europe doesn't require suffixes at all. How has this worked out for them? Is their system better or worse?
Globus: I don't think it's better or worse. It's just different. And the European Union went through a similar back-and-forth about this. They had initially proposed a 2-letter biologic qualifier, which they never put into practice.
Again, it depends on whose perspective you're looking at it, because from a patient perspective, if you look at the EU market, there are many more biosimilars. So, guess what? There's increased patient access. From an industry standpoint, it's easier for them because it's one less thing in the naming scheme that they have to deal with.
And then, from the safety signals standpoint, it's hard to tell because you have to look over long periods of time to see whether those adverse events reports and the things that are being tracked from a pharmacovigilance standpoint are coming in to the regulators, are those reports actionable, and how quickly they are actionable. So, I think from that standpoint, it's too early to tell. It very much depends on whose point of view you're looking at.
CfB: And lastly, do you have any concluding thoughts?
Globus: [Nothing other than] just getting the word out about what the requirements are, the role that a name can play in the occurrence of medication errors, and the resources that are out there to assist with those issues and in choosing screening, vetting, submitting, and approving.
CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia. Thanks for joining us.