What is a BioSimilar product under US Law?
Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner explains what can be classified as a BioSimilar product in the United States.
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Well, very interesting, what is a biosimilar product under US law? We talked about how in a functional sense and in a technical sense what a biosimilar is. It’s a polypeptide. It’s similar to – it’s complex, it has all kinds of other stuff mixed with it. That’s what you take when you take a biosimilar. You take all this other stuff. It’s like wine. It’s unique in that it treats diseases that aren’t treatable by small molecules. The US law, like law in most countries, incorporates some of this, but it focuses on purity, as you might expect because, of course, the directive for the Food and Drug Administration is safety and efficacy. We want the drugs to be safe. We don’t want them to be like Thalidomide. Everybody remembers from the – I guess it was the early 60s what Thalidomide did. Thalidomide was actually a very good drug, but pregnant women started to take Thalidomide and they had babies that didn’t have arms, no arms and legs, one eye. It was terrible stuff ’cause it was a mutagenic drug.
So we want drugs to be safe. No side effects. No unexpected effects. And we want them to be efficacious. We don’t want to send snake oil medicine. And we want the drugs to do what they say they do. All right? So that’s what the directive for the FDA is. So in a minute we’ll talk about what the specifics are.