How about approvals of BioSimilars in Europe?
Minneapolis patent attorney Jim Nelson of Schwegman, Lundberg & Woessner discusses BioSimilars in the European Union.
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Well, very interesting, I think the United States is very conservative when it comes to biosimilars. Let me give you an analogy. Unlike small molecules, which are structures that are easily identified that can be precisely purified and 100 percent of the drug that you take is the small molecule like Lipitor, biologicals are more like wine, as I said before. Everybody knows that if you want to make a red wine, you want to make a cabernet, that if you buy a cabernet from Napa Valley, it’s gonna taste different from a cabernet from Chili and taste different from a cabernet that comes from the Bordeaux region. They’re all different. In fact, if you like, let’s say, the Rutherford cabernet from Sonoma Valley and you buy a 2009 Rutherford cabernet and then you go back to the store a year – a week later and there are no more 2009s, there’s a 2010, so you try it, you realize it’s different. It’s different. It has a different taste, different mouth feel. It’s very different.
So that’s why biologicals are difficult to produce. Well, the United States being conservative in terms of allowing pharmaceutical companies to sell drugs to humans, of course, we want things to be safe and we want them to be effective, the United States is very conservative because there is so much variation in the production of these biologicals just like there’s so much variation in the production and development of wine.