BioSimilars Attorney in Minneapolis, Minnesota


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

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Sponsor. I’ve been using the term sponsor, and I will use the term sponsor in our discussions. And a sponsor of a biological is the original producer, the one who has gone to the FDA and said, “Okay, I have this new product, this new polypeptide, this new biological, and it’s for treatment of the common cold, it’s for treatment of breast cancer. Here’s all the information about it. I need to have you approve it, Mr. FDA.” And it’s the first product on the market and it’s the product that’s produced by the originator. And in the law, that party, that person is called sponsor. He sponsors this drug for the first time. Subsequent producers of the same drug are called biosimilar producers. Like the name implies, they’re the ones who are gonna try to produce the same drug as the sponsor has produced.

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