BioSimilars Attorney in Minneapolis, Minnesota

Biologics Price Competition and Innovation Act

Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner discusses the BPCIA.

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Well, the biologics Price and Competition Act was part of the Healthcare Act from 2009. Obama Care, if you will. And the Biologicals Price and Competition Act did the same thing for biologicals like Herceptin or insulin or other – Erythropoietin, which are very technical words, but nevertheless, they are proteins, very large molecules that are used to treat disease. And they’re proteins. They’re polypeptides rather than small molecules. So this act does the same thing for biologicals that the Hatch-Waxman act did for small molecules like penicillin or Lipitor, which is Atorvastatin. Those are all small molecules that are pharmaceutical compounds. And for many, many years since – let’s see. I think since the early ’80s or mid-’80s we’ve had Hatch-Waxman Act, which has provided the ability for other companies to piggyback their clinical studies on the clinical studies done by the original developer.

That’s the same thing that goes on with the biosimilars. As a second company or fifth company into the business, if you want to make a biological, a polypeptide like Herceptin, the monoclonal antibody for treatment of breast cancer, you would try to make the same thing, you make a demonstration using analytical techniques, and then if you show that you have the same thing or very close to it, you are able to market it without going through the extensive clinical studies. Clinical studies are we test the drug in humans after many, many, many months and many other studies in animals. We test the drugs in humans for safety and efficacy to make sure they work the way you expect, make sure there aren’t any side effects, all that sort of thing. So that’s what the biological Price and Competition Act was all about.

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