Are BioSimilars being approved in the US?
Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner discusses BioSimilars in the United States.
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Interesting question, are biologicals approved in the US? There is no approved biosimilar in the United States. There’s only one that has been accepted for review by the FDA. It’s Novartis Sandoz product for Filigastrin, which is a polypeptide, a very large polypeptide, but there are no approved biosimilars in the United States. Interestingly, Europe and other parts of the world are far ahead of the United States in terms of approval of biosimilars. And as I said before, the biosimilar is actually a “knockoff” of an original biological or polypeptide product that is already on the market. And the fact that you can – they call it a biosimilar company, can sell the biosimilars as a result of this Price and Competition Act so that the idea is that if there are two companies celling the same product, it will push down the price. Just like the generic sales of small molecules like the generic sales of Lipitor have pushed down the price for the small molecule pharmaceuticals.