Clinical Advances and Challenges With Biosimilars - Episode 7

Physician Understanding of Biologic Manufacturing

Bruce A. Feinberg, DO: To the point that, Hope, you’re asking about, and Marcus, you’re addressing, what do you think is the level of familiarity with rank-and-file physicians about the nuance of biologic manufacturing?

Marcus H. Snow, MD: I think it’s not large. I think that this is something that the basic scientists, the PhDs who deal with this, have known this for years. But I think that rheumatologists who write for infliximab think infliximab is infliximab. And it’s very, very, very, very similar. But at the same time, the infliximab of today is different than infliximab of 2005.

Hope S. Rugo, MD: Yes. It’s just so interesting to me because I only learned about this…

Bruce A. Feinberg, DO: But you were doing the clinical trials?

Hope S. Rugo, MD: Even before we started the trials, I’ve been using trastuzumab since it was approved. And we did bevacizumab studies, all the new antibodies, etc, and never thought about that. Then, we had this conversation with the FDA as we were designing a biosimilar trastuzumab trial, and the FDA said, “You’re going to have to do an initial trial in healthy people showing that Europe’s and the United States’ trastuzumab have the same pharmacokinetic equivalence and immunogenicity.” I’m like, “Really? Is that true?” And it’s been fascinating. That was a long time ago, now, to understand that they really were considered different by the FDA, how they’re made, and their processes.

Marcus H. Snow, MD: Yes, it’s something that opened my eyes as I was reviewing this. Much like you mentioned, I think it is something that is important to know. But moving forward, I think we still are going to need to have continued pharmacovigilance of each product as they hit the market.

Hope S. Rugo, MD: Absolutely.

Marcus H. Snow, MD: This is just the beginning—once these medications hit the market.

Bruce A. Feinberg, DO: So, you address the issue of pharmacovigilance with these products that are going to have to be ongoing. Do you anticipate your institution will be trying to get some idea of comparative effectiveness, even if it’s just through a real world evidence—based analysis as these drugs come into the market?

Marcus H. Snow, MD: Yes, I would hope so. I don’t know if, ultimately, we will be one of the sites. As we review this, as rheumatologists, I would hope for real world experience in reporting, not just in studies. With what we can do with electronic medical records nowadays, the American College of Rheumatology has its own network that can extract data from electronic medical records once the appropriate permissions have been procured. And hopefully we’ll be able to monitor things like this, monitor drugs, and make sure that there are no unusual safety signals that develop after 5 years of use or 10 years of use or switching from one version to another version and back to another version.