Post-Market Pharmacovigilance

Bruce A. Feinberg, DO: Would you still want to be doing pharmacovigilance postmarket release for the Mylan product if, and when, it comes to market?

Hope S. Rugo, MD: There’s no question that pharmacovigilance is incredibly important for all agents. I always tell people, “This is a biosimilar, so it’s very different from using another drug.” But, when you think about it, when any drug goes on the market, pharmacovigilance is incredibly important. In something as simple as a nonsteroidal, we saw a drug go off the market, Vioxx, because of postmarketing vigilance. So, I think that this is very important for all agents, when you have a new product going on the market. And a biosimilar is a new product, so pharmacovigilance is going to be critical. That is part of the regulatory direction for these agents, so pharmacovigilance will be part of this.

In terms of whether the Mylan product will go on the market or not, I think the study met all of the criteria set forth by the regulatory agents. So, it’s more of an issue of production and how production will happen in terms of approval or not. I don’t think there’s any question that these drugs will move forward. And, in the Oncology Drugs Advisory Committee meeting, recently, which was the first to evaluate oncology therapeutics, for both oncology therapeutics that were reviewed— bevacizumab in the morning and our trastuzumab product in the afternoon—there was a 100% vote of “Yes.”