Breast Cancer Update, Issue 2, 2016 (Video Program) - Video 15Perspective on biosimilar agents and the HERITAGE study of a trastuzumab biosimilar
3:25 minutes.
TRANSCRIPTION:
DR LOVE: So another HER2 data set I want to ask you about, and it really ties into a much large issue. And I don’t know whether you got involved with any discussions about this in your work as ASCO President: Biosimilars. DR SLEDGE: Yes. DR LOVE: So I don’t remember seeing a Phase III study of a biosimilar before in cancer, but here we saw the HERITAGE study at ASCO, Hope Rugo presented, looking at Myl-14010, a biosimilar to trastuzumab. What did they look at, and what do you think about these data? DR SLEDGE: I guess the first thing to say is that what we mean by a “biosimilar” is a biologic agent that is, indeed, similar to but not identical to the original molecule. So if we’re talking about lisinopril and someone comes out with a new lisinopril, it’s absolutely the same molecule. That’s a medicinal chemistry question. One can actually absolutely make something identical. It’s much harder to do that when one’s talking about biologics. So, therefore, we’re talking about biosimilar rather than bioidentical. And the regulatory agencies both here and Europe have come up with very nice criteria for what degree of similarity is required, both from a molecular standpoint but also from an efficacy and a safety standpoint. We’ve already seen biosimilars on the market. So, for instance, there’s a filgrastim biosimilar now that is making its way across the United States and was FDA approved within the last year or so. That biosimilar actually had been on the market in Europe for something like 6 or 7 years now, so we were a little bit behind our European colleagues in terms of developing a process for biosimilars and getting drugs on the market. I would say certainly the data that Hope Rugo presented suggests to me that it is absolutely reasonable to use a biosimilar. I suspect very strongly that what we’re going to see is a reduction in the cost of HER2-targeted therapy with trastuzumab-like agents in the fairly near future. And as more of these agents come on the market, we’ll probably see further reductions in the cost and more competition. And from my standpoint, that’s a good thing for the American healthcare system and that’s a good thing for patients. DR LOVE: So this looked at it in the metastatic setting where there’s a lot of variables. You can’t have thousands of patients, whatever. But, on the other hand, you don’t cure people. Would you see this kind of evidence being used to justify using it, for example, in the adjuvant/neoadjuvant situation, or do you think you need data there? DR SLEDGE: I’d personally be very comfortable with that. I think the metastatic setting, at least as far as HER2-targeted therapy, is certainly a good surrogate for the adjuvant setting. I don’t think that with every biosimilar we’re going to need to do a 5,000-patient N9831-type trial. |