What is needed to demonstrate BioSimilarity under U.S. law?
Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner discusses how to demonstrate BioSimilarity in the United States.
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What’s very interesting, it’s a very specific set of requirements to demonstrate biosimilarity under US law. And it’s kind of like demonstrating similarity for small molecules, for pharmaceuticals under the Hatch-Waxman Act, but there are some differences. Now, under FDA law, there are two major requirements. Safety and efficacy. And in the safety situation, we’re reminded of the Thalidomide fiasco, the Thalidomide scare from the early ’60s. Thalidomide was a very good drug. Unfortunately, it was also mutagenic and so doctors didn’t know that, they prescribed it to pregnant women, and it caused mutagenesis of the unborn fetus, and so babies were born without arms, without legs, without tongues. It was terrible, terrible stuff. So the safety aspect is very, very important. And, of course, we don’t want to sell snake oil medicine. We want to sell drugs that do what we say they do. So they have to be demonstrated to be efficacious.