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Ginsberg: This is Seth Ginsberg filling in for Lisa Wexler here and we have a very smart guy on the line here. Dr. Richard Dolinar calling in from Phoenix, Arizona. Hey, Dr.Dolinar.
Dolinar: Yes, Good afternoon.
Ginsberg: You've testified before the U.S. Senate subcommittee on Consumer Affairs and you’ve given congressional briefings on Capitol Hill and you're the expert when it comes to biosimilars. What are biosimilars?
Dolinar: Well, biosimilars are copies of trade name biologic drugs whose patents have expired. Many of the Biologics are quite complex, large molecular drugs and unlike the drugs that are made by chemical reactions, biologics are manufactured using living cells and that's a big difference between them and the chemical drugs so for example if we had aspirin- aspirin is made by a chemical process, chemical reactions- but if you take a biologic that I use very frequently with my patients – insulin- that's made using living cells. The easy way to look at it would be, you grow a redwood tree, you don't manufacture a redwood tree. We can manufacture a car, but when it comes to making a tree, like a redwood tree, we plant the seed, we grow it. We understand there are a number of companies with biosimilars in the final testing stages here in the United States. And I think you're going to start seeing them on the market pretty soon.
Ginsberg: Will they be cheaper?
Dolinar: Yes, we believe they are going to be cheaper, yes.
Ginsberg: And so now what does the FDA still have to rule on? What are some of the outstanding issues that we have to deal with?
Dolinar: Well, one issue involves naming. When we have the original biologic and we have the biosimilar, should we call them by the same name? There are some people who would like to give them the same name. I prefer that they have different names, that they have a distinguishable component in them, in the non-proprietary means, so that I as a physician can differentiate one from another so if there's an adverse event, we'll be able to identify 'okay, which drug was causing the problem?' and can fix that problem
Ginsberg: So you're the chairman of something called the 'Alliance for Safe Biologics.' Can you take a minute just to explain what that is?
Dolinar: Right, I'm the chairman of the "Alliance for Safe Biologic Medicines" and this is an organization that came together a few years ago and we consist of patients, physicians, scientists, pharmacists and we've come together to work to ensure that patient safety is kept at the forefront of policy decisions involving Biologics and Biosimilar drugs. So we've been very active in that regard.
Ginsberg: So, and you know, I think one other point worth mentioning here, we deal with generic medicines at least, very often we go to the pharmacy and when we get our prescription filled, we wind up getting something that's a generic and that's kind of the deal and that's what we live with. Is that something we can potentially face here when it comes to these more complex medicines for MS or RA or cancer, psoriasis? Is it switching is something we should be concerned about?
Dolinar: That's an interesting topic you bring up and that takes us to the state level. In the Affordable Care Act not only about tasks the FDA with finding an abbreviated approval process but it established a certain type of biosimilar which is called and interchangeable biosimilar which would be, which could be switched by the pharmacist without the intervention of a physician. That's the definition at the federal level. At the state level is where determination is made as to what pharmacists can do and right now, there is a very active debate going on in each of them, in many other states as to whether we should inform the physician if that drug has been switched from a biologic to an interchangeable biosimilar.
Ginsberg: What sense would that make to inform a physician about the care they we're receiving? I mean c'mon now.
Ginsberg: Well, Dr. Dolinar, I appreciate it, we're running short on time and I want to thank you for calling in. Where can folks go to learn more about the subject were talking about here?
Dolinar: Oh, you can go to our website www.safeBiologics.org on the Internet and I think they could find plenty of information there.
Ginsberg: Dr. Dolinar, we really appreciate it and thank you again. By the way, I forgot to mention that you served as flight surgeon in the Vietnam War and you're retired U.S. Air Force Colonel. So sir, thank you for your service and of course, for your insights today in a very important subject and we appreciate the time.
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