What is the naming problem with BioSimilars?

Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner explains the naming problems with BioSimilars.

Contact Jim Nelson

Email: [email protected]

Phone: (612) 373-6939

Transcript:

So the naming problem with biosimilars stems from who’s gonna administer this biosimilar? Now, I mentioned Lipitor. And, of course, everybody knows the brand name Lipitor. And the generic name for Lipitor – this is a small molecule, pharmaceutical. The generic name for Lipitor is Atorvastatin. And so now that there are a number of companies making the same thing, they all sell it as Atorvastatin. And if you look on the label of the bottle that Dr. Reddy provides or that Watson Pharmaceutical provides or that Mylan provides, it says Atorvastatin. It doesn’t say Lipitor because that’s a trademark of the Pfizer Company. It says Atorvastatin. So all of these generics have the same name. Atorvastatin. And it’s the same generic name as Lipitor. In fact, on the Lipitor bottle, you would see the generic name Atorvastatin.

What’s the point? The point is that if you are in the hospital and the nurse is gonna administer a drug to you, the nurse is gonna take a look and see, “Okay, I’ve got six bottles of Atorvastatin here. Some are made by Dr. Reddy, some are made by Watson, some are made by Pfizer, but it’s all the same thing, so I’ll just grab one.” All right? And it is all the same thing. All right? The biosimilars companies would like to have the same rules apply to biosimilars so that if there’s a biosimilar for Herceptin, a product for treating breast cancer, and let’s say that the generic name is monoclonal antibody six, all right? And so all the different bottles by all the different biosimilars would have the same name. Monoclonal antibody number six. All right? Then that’s what’s on the label. So the nurse can walk in, and she’ll just pick one of the monoclonal antibody number six off the shelf and administer it.

That’s what the biosimilars would like to do because that way it helps. But if the nurse goes into the pharmacy and she sees that, “Oh, well, there’s Herceptin and then there are these others and they’re not called monoclonal antibody number six, they’re called monoclonal antibody number ten or they’re called junk number seven”, for example, “well, I’m personally responsible for administering this drug, and the prescription says monoclonal antibody number six. And so I’m gonna take this Herceptin. I’m not gonna do number ten, I’m not gonna do junk number six because I don’t want to get in trouble.” And so that is the problem with the naming is that, of course, the sponsors would like the biosimilars’ names to be different and the biosimilars would like the generic name to be all the same for the reason that if – for the sponsors, for the originators, if the name is different, they know that when the nurse goes in to pick the drug, the nurse will always pick the sponsor’s original drug and not the biosimilars.

And the biosimilars will say, “Wait a minute. Ours is supposed to be the same. That’s what the FDA said. And so the names ought to be the same so the nurse can go pick the biosimilar.” Therein is the problem. And it’s both a state problem and a hospital-liability problem. Big issue.